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Bone screw sterile +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129786371SModel ScrewRef 397129786381SRef 397129795311SRef 397129786331SRef 397129786341SRef 397129786351S
by MEDIN, a.s.
Identity
- Trade Name
- Bone screw sterile; cortical, cannulated, self-tapping, HA 3.5×40/14 mm EUDAMEDBone screw sterile; cortical, cannulated, self-tapping, HA 3.5×45/15 mm EUDAMEDBone screw sterile; cortical, self-tapping, HA 3.5×30 mm EUDAMEDBone screw sterile; cortical, cannulated, self-tapping, HA 3.5×26/12 mm EUDAMEDBone screw sterile; cortical, cannulated, self-tapping, HA 3.5×28/14 mm EUDAMEDBone screw sterile; cortical, cannulated, self-tapping, HA 3.5×30/14 mm EUDAMED
- Device Name
- Bone screw sterile EUDAMED
- Model / Reference
- Screw EUDAMED397129786371S EUDAMED397129786381S EUDAMED397129795311S EUDAMED397129786331S EUDAMED397129786341S EUDAMED397129786351S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712388644 EUDAMED08591712388651 EUDAMED08591712387333 EUDAMED08591712388606 EUDAMED08591712388613 EUDAMED08591712388620 EUDAMED
- Basic UDI-DI
- 85917126030101SP9 EUDAMED
- Direct Marketing DI
- 08591712388644 EUDAMED08591712388651 EUDAMED08591712387333 EUDAMED08591712388606 EUDAMED08591712388613 EUDAMED08591712388620 EUDAMED
- EMDN Code
- P09120601 CORTICAL 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
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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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 | 85917126030101SP9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (6)
- EUDAMED 3be4305b-73b3-4d1f-b305-6c06037a3d4a 61 fields · synced Jul 27, 2026
- EUDAMED 11e79db0-c47d-4da4-b717-36fbc9d8f49d 61 fields · synced May 17, 2026
- EUDAMED 5c8333c1-9d52-40e1-9e28-0958111ab000 61 fields · synced May 17, 2026
- EUDAMED 36078225-21c7-469a-a122-1a1ab8754fdc 61 fields · synced May 18, 2026
- EUDAMED 9b88eb12-a0e5-4345-b937-19f38ccbfa29 61 fields · synced May 18, 2026
- EUDAMED 5f01cc83-b787-4b1a-b0c7-ba5440623170 61 fields · synced May 18, 2026