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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129796693SModel ScrewRef 397129774260SRef 397129774264SRef 397129774264
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; Ti, cancellous, self-tapping, HB 4×48 mm EUDAMEDBone screw sterile; cancellous, HB 4×48/15 mm EUDAMEDBone screw sterile; Ti, cancellous, self-tapping, HB 4×48/15 mm EUDAMEDBone screw; Ti, cancellous, self-tapping, HB 4×48/15 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMEDBone screw EUDAMED
- Model / Reference
- Screw EUDAMED397129796693S EUDAMED397129774260S EUDAMED397129774264S EUDAMED397129774264 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712391750 EUDAMED08591712391125 EUDAMED08591712391859 EUDAMED08591712390005 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED85917126030101VS EUDAMED
- Direct Marketing DI
- 08591712391750 EUDAMED08591712391125 EUDAMED08591712391859 EUDAMED08591712390005 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 (4)
- EUDAMED a69e02a7-6d6a-4fa4-a6e0-3435cf45958b 61 fields · synced Jul 27, 2026
- EUDAMED f7cd78f0-eb79-46d8-9d7b-005805e41400 61 fields · synced May 16, 2026
- EUDAMED f1305637-61db-45f6-bebf-cb85ce9285ae 61 fields · synced May 17, 2026
- EUDAMED 530360ff-1454-4d03-91b0-eb48dff8f2e0 61 fields · synced May 18, 2026