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Sagittal Split Plate Max. 10mm, t0.9
EUDAMEDClass IIb (EU MDR)
Ref M2-4051SRef M2-4051
by Medartis AG
Identity
- Trade Name
- Sagittal Split Plate Max. 10mm, t0.9 EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-4051S EUDAMEDM2-4051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037861508 EUDAMED07630037859536 EUDAMED
- Basic UDI-DI
- 76300378021P8 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Orthopaedic fixation plate, non-bioabsorbable
Sagittal Split Plate Max. 10mm, t0.9 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 | 76300378021P8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medartis AG
- EUDAMED SRN
- CH-MF-000022291
- Authorised Representative
- Medartis GmbH DE-AR-000005810
Sources (2)
- EUDAMED b4b2c408-8f3a-41c7-9499-cb41e6dfedfb 61 fields · synced Jul 11, 2026
- EUDAMED 7a63b153-1a7d-41f6-88cc-7ba1a018a6e0 61 fields · synced May 18, 2026