Company Profile
Karadeniz Cerrahi Aletler
Karadeniz Cerrahi Aletler ve İmplant San. Tic. A.Ş.
This facility was visited and verified on site. How we verify
Profile updated 15 Sept 2026Verified 6 May 2026 · valid until 6 May 2027
- Machines
- 16
- 16 verified
- Certifications
- 8
- Response time
- 6 hours
- Founded
- 1992
- Employees
- 51–200
- Facility
- 7,200 m²
Overview
About
1,400-item range from the Samsun surgical-instrument cluster: forged stainless hand instruments (forceps, scissors, retractors, orthopedic sets) and titanium trauma plates and screws. OEM manufacturing under ISO 13485 and MDR CE, shipped with UDI laser marking and ISO 13402 corrosion testing.
Shown: EnglishVerified by company
Language versions
- TurkishVerified by company
- EnglishVerified by company
- GermanAI translated
- Simplified ChineseAI translated
- Industries served
- Medical DevicesHospitals & Healthcare ProvidersVeterinary & Animal Health
- Export markets
- GermanyUnited StatesUnited KingdomSaudi ArabiaEgyptPakistanKazakhstan
- Business languages
- TurkishEnglishGerman
- Industrial zone
- Samsun Merkez OSB
Index snapshot
How it is calculated- Machine modernity
- 66/100
- 67th percentile in Medical Devices & Pharma Manufacturing
- Automation
- 55/100
- 100th percentile in Medical Devices & Pharma Manufacturing
- Certification strength
- 75/100
- 100th percentile in Medical Devices & Pharma Manufacturing
- Export readiness
- 84/100
- 100th 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.
Surgical Instrument Manufacturing
Stainless SteelTitanium- Tolerance
- ±0.02 mm
- Max. part size
- 450 mm
- Batch size
- 50 – 50k
- Evidence
- 5 machines as evidence
Implant Machining (Orthopedic, Spinal, Dental)
TitaniumStainless SteelCobalt-Chrome (CoCr / CoCrMo)- Tolerance
- ±0.01 mm
- Max. part size
- 300 mm
- Batch size
- 100 – 20k
- Evidence
- 3 machines as evidence
Swiss-Type Turning
TitaniumStainless Steel- Tolerance
- ±0.005 mm
- Max. part size
- 20 mm
- Batch size
- 500 – 200k
- Evidence
- 1 machine as evidence
Forging
Stainless Steel- Batch size
- 200 – 100k
- Evidence
- 1 machine as evidence
Legend:Factory verifiedDocument verifiedUnverified
Machine park16 machines
16 units · 16 verified · median year 2020 · 81% under 10 years · 0 with available capacity
Forging Press / Hammer
Yıldız Makina FVP 160 (friction screw press)
- Press Force
- 160 t
5-Axis Machining Center
Hermle C 22 U
- X Travel
- 450 mm
- Spindle Speed
- 18,000 rpm
Swiss-Type Lathe
Tsugami B0205-III
- Bar Capacity
- 20 mm
- Spindle Speed
- 12,000 rpm
Vertical Machining Center
Haas VF-2SS
- X Travel
- 762 mm
- Spindle Speed
- 12,000 rpm
Surgical Instrument Polishing & Finishing Line
OTEC DF-3 Tornado + manual buffing cells
UDI Laser Marking Station (Medical)
TRUMPF TruMark Station 5000 (TruMark 5020)
- Laser Power
- 0.02 kW
Heat Treatment Furnace
Ipsen Turbo2Treater M
- Max. Temperature
- 1,250 °C
Coordinate Measuring Machine
Mitutoyo CRYSTA-Apex S 574
- Measuring Accuracy (MPE)
- 1.7 µm
- Measuring Range
- 500 mm
Products & HS codes
Product families the company supplies, with Harmonized System codes for customs and sourcing.
Forged stainless hand instruments, orthopedic and dental instrument sets
Surgical Instruments (Forceps, Scissors, Retractors, Orthopedic Sets)
Declared by company
Other manufacturers of this product →Titanium locking plates, cortical/cancellous screws, external fixators
Orthopedic & Spinal Implants (Plates, Screws, Nails, Joint Prostheses)
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 40% deposit, balance before shipment · L/C at sight · Net 30 (EU OEM accounts) (As stated by the company)
Minimum order
Foreign-trade team
Capacity note
Monthly 60,000 surgical instruments and 25,000 implant screws/plates; forging, heat treatment and polishing in-house.
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) 0/3Missing: EU origin proof (A.TR; EUR.1 for ECSC steel); Incoterm with a named place; Coded payment terms
- FTA partners (GB, EG) 0/3Missing: FTA origin proof (EUR.1 / EUR-MED); Incoterm with a named place; Coded payment terms
- Other markets (US, SA, PK, KZ) 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
Ferrous Metals
- Stainless Steel
Non-Ferrous Metals
- Titanium
- Cobalt-Chrome (CoCr / CoCrMo)
Certificates
8 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
- TÜV SÜD
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 28 Feb 2028
- Scope
- Not provided
- Verification
- Factory verified · 10 Jun 2026
ISO 9001
Quality management system
Valid- Certificate no.
- Not provided
- Issued by
- TÜV SÜD
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 28 Feb 2028
- 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
- TÜV SÜD (NB 0123)
- Accreditation
- Accreditation not recorded
- Issued
- Not provided
- Valid until
- 28 Feb 2028
- Scope
- Not provided
- Verification
- Factory verified · 10 Jun 2026
CE
European conformity marking
Valid- Certificate no.
- Not provided
- Issued by
- Not provided
- Accreditation
- Not provided
- Issued
- Not provided
- Valid until
- 28 Feb 2028
- Scope
- Not provided
- Verification
- Factory verified · 10 Jun 2026
ISO 14971
Application of risk management to medical devices (risk file, FMEA, benefit-risk)
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
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
- Factory verified · 10 Jun 2026
FDA 510(k) / Registration
US FDA premarket notification 510(k) clearance and establishment registration / device listing (21 CFR 820 QMSR)
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
UDI (EUDAMED / GUDID)
Unique Device Identification — UDI-DI/PI assignment, GS1/HIBC coding, EUDAMED and FDA GUDID registration
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
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 system9 / 25
- Best QMS certificate (tier × credit)9 / 25
Special-process approvals0 / 15
- Approvals per special-process family0 / 15
Metrology14 / 20
- Measuring equipment evidence8 / 8
- Calibration records0 / 6
- Tolerance vs. measuring capability6 / 6
Quality processes2.5 / 15
- First article / PPAP1.5 / 5
- Process capability (SPC)0 / 4
- Material traceability1 / 4
- Nonconformance handling (8D)0 / 2
Verification & freshness14.6 / 15
- Company verification10 / 10
- Machine verification4.6 / 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 14971, FDA 510(k) / Registration, UDI (EUDAMED / GUDID)
InfoNo certificate number for a registry lookup: ISO 13485, EU MDR 2017/745, CE, ISO 9001, ISO 14971, ÜTS (TİTCK), FDA 510(k) / Registration, UDI (EUDAMED / GUDID)
InfoCertificate scope not published: ISO 13485, ISO 9001
InfoNo calibration records published for the measuring equipment
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.
Metrology & calibration
| Instrument | Measuring volume | MPE | Calibration | Verification |
|---|---|---|---|---|
| Mitutoyo CRYSTA-Apex S 574Coordinate Measuring Machine | — | 1.7 µm | No calibration record | Factory verified |
- Surgical Instrument Corrosion / Boil Test & Passivation Check (ISO 13402, ASTM A967)
- Device History Record & Lot Traceability (DHR / DMR)
- Implant Mechanical & Fatigue Testing (ASTM F1717, F2077, ISO 7206, ISO 14801)
- CMM Inspection
- Hardness Testing
- EN 10204 3.1 Material Certificates
- Surface Roughness Measurement
- First Article Inspection (FAI)
Contact
Address
Samsun Merkez OSB, Tekkeköy, Samsun, 55300
Türkiye
Website
karadenizcerrahi.exampleTypically responds within 6 hours
Direct contact
No phone or messaging channel published. Request a quote or use the website.
Company facts
- Sectors
- Medical Devices & Pharma Manufacturing, Metal Cutting & Precision Machining
- Founded
- 1992
- Employees
- 51–200
- Machines
- 16 (16 verified)
- Languages
- TR, EN, DE
- Response time
- 6 hours
- Verification
- Factory verified · 6 May 2026
Capability matrix
| Processes | Materials | Tolerance | Batch (pcs) |
|---|---|---|---|
| Surgical Instrument Manufacturing | Stainless Steel, Titanium | ±0.02 mm | 50 – 50k |
| Implant Machining (Orthopedic, Spinal, Dental) | Titanium, Stainless Steel, Cobalt-Chrome (CoCr / CoCrMo) | ±0.01 mm | 100 – 20k |
| Swiss-Type Turning | Titanium, Stainless Steel | ±0.005 mm | 500 – 200k |
| Forging | Stainless Steel | — | 200 – 100k |
Machine park
Swiss-Type Lathe × 4 (4 ✓) · Forging Press / Hammer × 3 (3 ✓) · Vertical Machining Center × 3 (3 ✓) · 5-Axis Machining Center × 2 (2 ✓) · Surgical Instrument Polishing & Finishing Line × 1 (1 ✓) · UDI Laser Marking Station (Medical) × 1 (1 ✓) · Heat Treatment Furnace × 1 (1 ✓) · Coordinate Measuring Machine × 1 (1 ✓)
Certificates
- ISO 13485 · TÜV SÜD · Valid until 28 Feb 2028 · Factory verified
- EU MDR 2017/745 · TÜV SÜD (NB 0123) · Valid until 28 Feb 2028 · Factory verified
- CE · — · Valid until 28 Feb 2028 · Factory verified
- ISO 9001 · TÜV SÜD · Valid until 28 Feb 2028 · Document verified
- ISO 14971 · — · Document verified
- ÜTS (TİTCK) · TİTCK · Factory verified
- FDA 510(k) / Registration · — · Document verified
- UDI (EUDAMED / GUDID) · — · Document verified
Trade & logistics
- Exports
- Yes — active exporter
- Export markets
- Germany, United States, United Kingdom, Saudi Arabia, Egypt, Pakistan, Kazakhstan
- Incoterms
- EXW, FCA, DAP
- Lead time
- 20–60 days
- Minimum order
- €5,000
- Payment terms
- T/T 40% deposit, balance before shipment; L/C at sight; Net 30 (EU OEM accounts)
Contact
- Location
- Tekkeköy, 55300, Samsun, Türkiye
- Web
- https://karadenizcerrahi.example
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Karadeniz Cerrahi Aletler