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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129796653SModel ScrewRef 397129796650SRef 397129796653
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; Ti, cancellous, self-tapping, HB 4×38 mm EUDAMEDBone screw sterile; cancellous, self-tapping, HB 4×38 mm EUDAMEDBone screw; Ti, cancellous, self-tapping, HB 4×38 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMEDBone screw EUDAMED
- Model / Reference
- Screw EUDAMED397129796653S EUDAMED397129796650S EUDAMED397129796653 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712391705 EUDAMED08591712390845 EUDAMED08591712389856 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED85917126030101VS EUDAMED
- Direct Marketing DI
- 08591712391705 EUDAMED08591712390845 EUDAMED08591712389856 EUDAMED
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
- Models / Variants
- Bone screw sterile EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone screw sterile +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85917126030101SP9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (3)
- EUDAMED ecf48b40-e59d-42fb-a132-021f8e3ff874 61 fields · synced Jul 30, 2026
- EUDAMED 2fc299c3-8174-4743-9175-b6a34524e591 61 fields · synced May 17, 2026
- EUDAMED ea414ae7-e974-4309-bcf4-13730fca511e 61 fields · synced May 18, 2026