Company Profile
Ege Steril Medikal
Ege Steril Medikal Ürünler San. ve Tic. A.Ş.
Verified from submitted documents. On-site verification pending. How we verify
Profile updated 15 Sept 2026Verified 14 Apr 2026
- Machines
- 29
- 23 verified
- Certifications
- 9
- Response time
- 8 hours
- Founded
- 2006
- Employees
- 201–500
- Facility
- 14,500 m²
Overview
About
Syringes, IV cannulas, infusion sets and urinary catheters made in a 3,200 m² ISO 7 cleanroom: 14 all-electric molding cells, 3 medical tubing extrusion lines, RF catheter tipping and a 10 m³ in-house ethylene oxide sterilizer. Annual capacity 180 million syringes and 40 million sets; ISO 13485, MDR CE and ÜTS registered.
Shown: EnglishVerified by company
Language versions
- TurkishVerified by company
- EnglishVerified by company
- GermanNot available
- Simplified ChineseNot available
- Industries served
- Medical DevicesHospitals & Healthcare ProvidersIn-Vitro Diagnostics & Laboratories
- Export markets
- GermanyItalyIraqSaudi ArabiaAlgeriaUzbekistanRomaniaUnited Kingdom
- Business languages
- TurkishEnglish
- Industrial zone
- Kemalpaşa OSB
Index snapshot
How it is calculated- Machine modernity
- 69/100
- 100th percentile in Medical Devices & Pharma Manufacturing
- Automation
- 0/100
- 67th percentile in Medical Devices & Pharma Manufacturing
- Certification strength
- 66/100
- 99th percentile in Medical Devices & Pharma Manufacturing
- Export readiness
- 81/100
- 97th percentile in Medical Devices & Pharma Manufacturing
Indices are computed from profile data and are not a quality rating.
Capability matrix
Each row is a process the company performs; columns show which materials are covered and the verification level of the evidence.
Medical Disposables Production
Medical-Grade Polypropylene (Syringe / Radiation-Stable)Polycarbonate (PC)ABSMedical-Grade Silicone (USP Class VI / Implant Grade)- Batch size
- 50k – 20m
- Evidence
- 3 machines as evidence
Medical Tubing & Catheter Extrusion
Medical PVC (DEHP-Free Compound)Polyamide (PA / Nylon)- Tolerance
- ±0.05 mm
- Max. part size
- 12 mm
- Batch size
- 5k – 5m
- Evidence
- 3 machines as evidence
Medical Device Assembly
Medical PVC (DEHP-Free Compound)Medical-Grade Polypropylene (Syringe / Radiation-Stable)ABS- Batch size
- 10k – 5m
- Evidence
- 2 machines as evidence
Ethylene Oxide (EO) Sterilization
- Batch size
- 1 – 40
- Evidence
- 1 machine as evidence
Medical Packaging (Sterile Barrier: Pouch, Tray, Blister)
Medical-Grade Polypropylene (Syringe / Radiation-Stable)- Batch size
- 5k – 2m
- Evidence
- 1 machine as evidence
Legend:Factory verifiedDocument verifiedUnverified
Machine park29 machines
29 units · 23 verified · median year 2020 · 100% under 10 years · 0 with available capacity
Medical Cleanroom Molding Cell
ENGEL e-motion 310/120 + viper 20 robot, laminar flow hood
- Clamping Force
- 120 t
Medical Cleanroom Molding Cell
Sumitomo (SHI) Demag IntElect 180/570-800 (48-cavity syringe barrel)
- Clamping Force
- 180 t
Medical Cleanroom Molding Cell
ARBURG ALLROUNDER 470 A (LSR package)
- Clamping Force
- 100 t
Medical Tubing Extrusion Line
Davis-Standard MEDD 32 mm medical extrusion line (Conair puller/cutter, laser gauge)
Medical Tubing Extrusion Line
Maillefer NCX 30 medical line
Catheter Tipping / Forming Machine (RF, Hot Air)
Beahm Designs 850-A RF tipping + 700-B hole puncher
Medical Cleanroom Molding Cell
Bosch Packaging / in-house Semi-automatic IV set assembly lines (12 stations)
Blister / Thermoform Packaging Machine (Pharma & Medical)
MULTIVAC R 145 (Tyvek / PETG medical thermoformer)
EO Sterilizer (Industrial Chamber)
Telstar EtO sterilizer 10 m³ with preconditioning and aeration rooms
- Max. Temperature
- 55 °C
Products & HS codes
Product families the company supplies, with Harmonized System codes for customs and sourcing.
2–60 ml Luer slip / Luer lock syringes, insulin syringes, safety needles
Syringes, Needles & Blood Collection Systems
Declared by company
Other manufacturers of this product →IV cannulas, infusion sets, Foley and Nelaton catheters, suction catheters
Catheters, Infusion / Transfusion Sets & Tubing Sets
Declared by company
Other manufacturers of this product →Urine containers, sample tubes (non-sterile and gamma-sterile)
Laboratory & IVD Consumables (Pipette Tips, Tubes, Plates, Swabs)
Declared by company
Other manufacturers of this product →
HS codes are indicative. Binding classification only via a BTB (Türkiye) or BTI (EU) ruling.
Trade & logistics
Exports
Export markets
Import sources
Incoterms® 2020 + named place
Lead time
Payment terms
T/T 30% deposit, balance against B/L copy · L/C at sight · CAD (As stated by the company)
Minimum order
Foreign-trade team
Capacity note
Annual 180 million syringes, 40 million infusion sets, 12 million catheters; lead time includes 14-day post-EO quarantine.
Logistics
Road transit to Germany: 4–6 days (indicative, by region)
Türkiye–EU Customs Union: industrial goods enter the EU duty-free with an A.TR certificate (agricultural and ECSC steel products excluded).
Lead time: from order confirmation to ex-works dispatch, unless stated otherwise.
Origin & customs guideExport readiness
6/146 of 14 applicable
- EU (DE, IT, RO) 0/3Missing: EU origin proof (A.TR; EUR.1 for ECSC steel); Incoterm with a named place; Coded payment terms
- FTA partners (GB) 0/3Missing: FTA origin proof (EUR.1 / EUR-MED); Incoterm with a named place; Coded payment terms
- Other markets (IQ, SA, DZ, UZ) 0/3Missing: Certificate of origin for other markets; Incoterm with a named place; Coded payment terms
- Active exporter with named markets — Met
- Products carry company-declared 6-digit HS codes — Met
- EU origin proof (A.TR; EUR.1 for ECSC steel) — Not declared
- FTA origin proof (EUR.1 / EUR-MED) — Not declared
- Certificate of origin for other markets — Not declared
- Incoterm with a named place — Not met(Not met)
- Coded payment terms — Not declared
- Sample and series lead times — Not declared
- Minimum order value — Met
- Named foreign-language contact — Not declared
- Valid, verified quality certificate — Met
- Verified capacity report — Not declared
- Responds within 24 hours — Met
- Profile updated within 12 months — Met
Export readiness from published data — not a certification.
Materials
Polymers
- Medical-Grade Polypropylene (Syringe / Radiation-Stable)
- Polycarbonate (PC)
- ABS
- Medical-Grade Silicone (USP Class VI / Implant Grade)
- Medical PVC (DEHP-Free Compound)
- Polyamide (PA / Nylon)
Certificates
9 current · 0 expiring within 90 days · 0 expired or inactive
Quality management
ISO 13485
Medical devices quality management
Valid- Certificate no.
- Not provided
- Issued by
- SGS
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 30 Sept 2027
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
ISO 9001
Quality management system
Valid- Certificate no.
- Not provided
- Issued by
- SGS
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 30 Sept 2027
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
Product & other
EU MDR 2017/745
EU Medical Device Regulation conformity for implants and patient-specific devices
Valid- Certificate no.
- Not provided
- Issued by
- SGS Belgium (NB 1639)
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 30 Sept 2027
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
CE
European conformity marking
Valid- Certificate no.
- Not provided
- Issued by
- Not provided
- Accreditation
- Not provided
- Issued
- Not provided
- Valid until
- 30 Sept 2027
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
ISO 11135
Ethylene oxide sterilization — development, validation and routine control
No expiry date- Certificate no.
- Not provided
- Issued by
- in-house validation, third-party audited
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- Not provided
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
ISO 10993
Biological evaluation of medical devices — biocompatibility testing (cytotoxicity, sensitization, irritation)
No expiry date- Certificate no.
- Not provided
- Issued by
- Not provided
- Accreditation
- Not provided
- Issued
- Not provided
- Valid until
- Not provided
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
ISO 11607
Packaging for terminally sterilized medical devices — sterile barrier system materials and sealing process validation
No expiry date- Certificate no.
- Not provided
- Issued by
- Not provided
- Accreditation
- Not provided
- Issued
- Not provided
- Valid until
- Not provided
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
ISO 14644
Cleanroom classification and monitoring (ISO Class 5–8 molding rooms)
No expiry date- Certificate no.
- Not provided
- Issued by
- Not provided
- Accreditation
- Not provided
- Issued
- Not provided
- Valid until
- Not provided
- Scope
- Not provided
- Verification
- Unverified
ÜTS (TİTCK)
Registration in the Turkish Product Tracking System (ÜTS) of TİTCK — mandatory for placing medical devices on the Turkish market and for public tenders
No expiry date- Certificate no.
- Not provided
- Issued by
- TİTCK
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- Not provided
- Scope
- Not provided
- Verification
- Document verified · 2 Apr 2026
Standard codes are shown as issued and are never translated.
Quality & inspection
Quality evidence readiness
Rates the evidence published on this profile — not the quality of parts.
Quality management system6.3 / 25
- Best QMS certificate (tier × credit)6.3 / 25
Special-process approvals0 / 15
- Approvals per special-process family0 / 15
Metrology0 / 20
- Measuring equipment evidence0 / 8
- Calibration records0 / 6
- Tolerance vs. measuring capability0 / 6
Quality processes1 / 15
- First article / PPAP0 / 5
- Process capability (SPC)1 / 4
- Material traceability0 / 4
- Nonconformance handling (8D)0 / 2
Verification & freshness8.8 / 15
- Company verification6 / 10
- Machine verification2.8 / 5
Personnel qualificationNot applicable
How is this computed?
Certificate credit = validity × evidence × issuer legitimacy × completeness. Each component earns points; components that do not apply to this company are removed from the denominator. Score = 100 × points earned ÷ applicable points. A critical flag lowers the band by one level. Calibration records and company-declared quality-system details are not captured yet and count as not demonstrated.
Computed 22 Oct 2026
Quality flags
Computed automatically from the published data. A flag is a question to ask the supplier, not a verdict.
WarningNo issuing body recorded: CE, ISO 10993, ISO 11607, ISO 14644
InfoNo certificate number for a registry lookup: ISO 13485, EU MDR 2017/745, CE, ISO 11135, ISO 10993, ISO 11607, ISO 14644, ÜTS (TİTCK), ISO 9001
InfoCertificate scope not published: ISO 13485, ISO 9001
Quality system
- First-article inspection
- Not declared
- Process capability
- Not declared
- Traceability
- Not declared
- Non-conformance handling
- Not declared
- NDT personnel
- Not declared
- Last external audit
- Not declared
The company has not declared its quality system yet.
- Bioburden Testing (ISO 11737-1)
- Sterility Testing (ISO 11737-2 / USP <71>)
- Bacterial Endotoxin / LAL Testing (USP <85>)
- Sterile Barrier / Package Integrity Testing (ASTM F1929, F2096, F88)
- Cleanroom Particle & Environmental Monitoring (ISO 14644-1, Annex 1)
- Device History Record & Lot Traceability (DHR / DMR)
- Biocompatibility Testing (ISO 10993 Series)
- Statistical Process Control (SPC)
Contact
Address
Kemalpaşa OSB, Kemalpaşa, İzmir, 35730
Türkiye
Website
egesteril.exampleTypically responds within 8 hours
Direct contact
No phone or messaging channel published. Request a quote or use the website.
Company facts
- Sectors
- Medical Devices & Pharma Manufacturing
- Founded
- 2006
- Employees
- 201–500
- Machines
- 29 (23 verified)
- Languages
- TR, EN
- Response time
- 8 hours
- Verification
- Document verified · 14 Apr 2026
Capability matrix
| Processes | Materials | Tolerance | Batch (pcs) |
|---|---|---|---|
| Medical Disposables Production | Medical-Grade Polypropylene (Syringe / Radiation-Stable), Polycarbonate (PC), ABS, Medical-Grade Silicone (USP Class VI / Implant Grade) | — | 50k – 20m |
| Medical Tubing & Catheter Extrusion | Medical PVC (DEHP-Free Compound), Polyamide (PA / Nylon) | ±0.05 mm | 5k – 5m |
| Medical Device Assembly | Medical PVC (DEHP-Free Compound), Medical-Grade Polypropylene (Syringe / Radiation-Stable), ABS | — | 10k – 5m |
| Ethylene Oxide (EO) Sterilization | — | 1 – 40 | |
| Medical Packaging (Sterile Barrier: Pouch, Tray, Blister) | Medical-Grade Polypropylene (Syringe / Radiation-Stable) | — | 5k – 2m |
Machine park
Medical Cleanroom Molding Cell × 20 (14 ✓) · Medical Tubing Extrusion Line × 3 (3 ✓) · Catheter Tipping / Forming Machine (RF, Hot Air) × 3 (3 ✓) · Blister / Thermoform Packaging Machine (Pharma & Medical) × 2 (2 ✓) · EO Sterilizer (Industrial Chamber) × 1 (1 ✓)
Certificates
- ISO 13485 · SGS · Valid until 30 Sept 2027 · Document verified
- EU MDR 2017/745 · SGS Belgium (NB 1639) · Valid until 30 Sept 2027 · Document verified
- CE · — · Valid until 30 Sept 2027 · Document verified
- ISO 11135 · in-house validation, third-party audited · Document verified
- ISO 10993 · — · Document verified
- ISO 11607 · — · Document verified
- ISO 14644 · — · Unverified
- ÜTS (TİTCK) · TİTCK · Document verified
- ISO 9001 · SGS · Valid until 30 Sept 2027 · Document verified
Trade & logistics
- Exports
- Yes — active exporter
- Export markets
- Germany, Italy, Iraq, Saudi Arabia, Algeria, Uzbekistan, Romania, United Kingdom
- Incoterms
- EXW, FOB, CIF, DAP
- Lead time
- 30–75 days
- Minimum order
- US$15,000
- Payment terms
- T/T 30% deposit, balance against B/L copy; L/C at sight; CAD
Contact
- Location
- Kemalpaşa, 35730, İzmir, Türkiye
- Web
- https://egesteril.example
Similar manufacturers
Ready to request a quote?
Ege Steril Medikal