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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129795205SModel ScrewRef 397129795204S
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; Ti, cortical, HA 3.5×8 mm, T15 EUDAMEDBone screw sterile; Ti, cortical, self-tapping, HA 3.5×8 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMED
- Model / Reference
- Screw EUDAMED397129795205S EUDAMED397129795204S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712405020 EUDAMED08591712387920 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED
- Direct Marketing DI
- 08591712405020 EUDAMED08591712387920 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- Models / Variants
- Bone screw sterile EUDAMEDTi, cortical, HA 3.5×8 mm, T15 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
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 sterile +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
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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 da619c21-099b-48f3-9281-b0a2a6488369 61 fields · synced Jul 8, 2026
- EUDAMED e65465e4-ee3a-45d7-9db0-1325f2dbac6f 61 fields · synced May 18, 2026