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Sagittal Split Plate 4Hole Max.10mm, t1.0
EUDAMEDClass IIb (EU MDR)
Ref M2-4063Ref M2-4063S
by Medartis AG
Identity
- Trade Name
- Sagittal Split Plate 4Hole Max.10mm,t1.0 EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-4063 EUDAMEDM2-4063S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037859574 EUDAMED07630037861546 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
No
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 4Hole Max.10mm, t1.0 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 7a720572-03d9-4516-a6a3-8b061406c4e7 61 fields · synced Jul 28, 2026
- EUDAMED 821dc9b3-bb45-4673-a241-7e984c0db935 61 fields · synced May 17, 2026