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2.3 Cortical Screw 08mm, HD6, 1/Pkg
EUDAMEDClass IIb (EU MDR)
Ref M2-5250.08/1
by Medartis AG
Identity
- Trade Name
- 2.3 Cortical Screw 08mm, HD6, 1/Pkg EUDAMED
- Device Name
- Bone screws (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-5250.08/1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037876687 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
No
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)
2.3 Cortical Screw 08mm, HD6, 1/Pkg by Medartis AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 8ab90bc2-2c2c-456e-9292-da0b3e56e005 61 fields · synced Jul 29, 2026