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Bone screw +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129796721Model ScrewRef 397129796721SRef 397129796421S
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw; cancellous, self-tapping, HB 6.5×35/16 mm EUDAMEDBone screw sterile; cancellous, self-tapping, HB 6.5×35/16 mm EUDAMEDBone screw sterile; cancellous, self-tapping, HB 6.5×35 mm EUDAMED
- Device Name
- Bone screw EUDAMEDBone screw sterile EUDAMED
- Model / Reference
- Screw EUDAMED397129796721 EUDAMED397129796721S EUDAMED397129796421S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712389399 EUDAMED08591712391248 EUDAMED08591712391187 EUDAMED
- Basic UDI-DI
- 85917126030101VS EUDAMED85917126030101SP9 EUDAMED
- Direct Marketing DI
- 08591712389399 EUDAMED08591712391248 EUDAMED08591712391187 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 +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 | 85917126030101VS | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (3)
- EUDAMED b0009c13-b857-4a2a-aeb6-5b0e80f03879 61 fields · synced Sep 18, 2026
- EUDAMED e2f29322-52ba-4f64-874c-59ea7bd68642 61 fields · synced May 18, 2026
- EUDAMED 585621f5-9e93-48af-9bcf-5656590dcc69 61 fields · synced May 19, 2026