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Bone screw - Bone screw
EUDAMEDClass IIb (EU MDR)
Ref 397129796663Model ScrewRef 397129796663S
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw; Ti, cancellous, self-tapping, HB 4×42 mm EUDAMEDBone screw sterile; Ti, cancellous, self-tapping, HB 4×42 mm EUDAMED
- Device Name
- Bone screw EUDAMEDBone screw sterile EUDAMED
- Model / Reference
- Screw EUDAMED397129796663 EUDAMED397129796663S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712389870 EUDAMED08591712391729 EUDAMED
- Basic UDI-DI
- 85917126030101VS EUDAMED85917126030101SP9 EUDAMED
- Direct Marketing DI
- 08591712389870 EUDAMED08591712391729 EUDAMED
- EMDN Code
- P09120602 CANCELLOUS SCREWS EUDAMED
- Models / Variants
- Bone screw EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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 - Bone screw 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 | 85917126030101VS | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED c68d93ad-88aa-4a17-9829-ed7445d27cce 61 fields · synced Jul 9, 2026
- EUDAMED a636fb2f-d552-4674-83f4-b0ce1b9bb522 61 fields · synced May 17, 2026