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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129797001SModel ScrewRef 397129796831S
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; cancellous, self-tapping, HB 6.5×90/32 mm EUDAMEDBone screw sterile; cancellous, self-tapping, HB 6.5×90/16 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMED
- Model / Reference
- Screw EUDAMED397129797001S EUDAMED397129796831S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712391514 EUDAMED08591712391354 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED
- Direct Marketing DI
- 08591712391514 EUDAMED08591712391354 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
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
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 (2)
- EUDAMED 883df8ce-4a12-4af0-8c74-d8397534bb47 61 fields · synced Oct 6, 2026
- EUDAMED 0111c014-c28c-4655-b2f2-91b4c8042206 61 fields · synced May 17, 2026