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1.2 Cortical Screw 05mm, HD4
EUDAMEDClass IIb (EU MDR)
Ref M2-5214.05/1S
by Medartis AG
Identity
- Trade Name
- 1.2 Cortical Screw 05mm, HD4 EUDAMED
- Device Name
- Bone screws (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-5214.05/1S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037874744 EUDAMED
- Basic UDI-DI
- 76300378022PA EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
1.2 Cortical Screw 05mm, HD4 by Medartis AG — Class IIb — MDR — listed in EUDAMED — 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 | 76300378022PA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (1)
- EUDAMED 0e4295fb-2391-4ea2-8aed-9abdca7b59da 61 fields · synced Sep 17, 2026