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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129795631SModel ScrewRef 397129795631
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; cortical, self-tapping, HA 4.5×65 mm EUDAMEDBone screw; cortical, self-tapping, HA 4.5×65 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMEDBone screw EUDAMED
- Model / Reference
- Screw EUDAMED397129795631S EUDAMED397129795631 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712387555 EUDAMED08591712385735 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED85917126030101VS EUDAMED
- Direct Marketing DI
- 08591712387555 EUDAMED08591712385735 EUDAMED
- EMDN Code
- P09120601 CORTICAL 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
Category: Orthopaedic bone screw (non-sliding)
Bone screw sterile +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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 (2)
- EUDAMED 4187ba54-a647-4fea-a1d2-f8425544071c 61 fields · synced Jul 16, 2026
- EUDAMED e2dec330-1636-4c40-a927-163c07edfe64 61 fields · synced May 18, 2026