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Bone screw +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129795221Model ScrewRef 397129795224
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw; cortical, self-tapping, HA 3.5×12 mm EUDAMEDBone screw; Ti, cortical, self-tapping, HA 3.5×12 mm EUDAMED
- Device Name
- Bone screw EUDAMED
- Model / Reference
- Screw EUDAMED397129795221 EUDAMED397129795224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712385421 EUDAMED08591712386121 EUDAMED
- Basic UDI-DI
- 85917126030101VS EUDAMED
- Direct Marketing DI
- 08591712385421 EUDAMED08591712386121 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- Models / Variants
- Bone screw EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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 +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 | 85917126030101VS | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED 8fbb322a-05e2-49be-8097-c800908b23f4 61 fields · synced Aug 3, 2026
- EUDAMED 4eaa93ea-77a3-4a91-94e1-f0fb2dfc6252 61 fields · synced May 18, 2026