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Sagittal Split Plate Max. 10mm, t0.7
EUDAMEDClass IIb (EU MDR)
Ref M2-4048Ref M2-4048S
by Medartis AG
Identity
- Trade Name
- Sagittal Split Plate Max. 10mm, t0.7 EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-4048 EUDAMEDM2-4048S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037859505 EUDAMED07630037861478 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
Sagittal Split Plate Max. 10mm, t0.7 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 | 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 3d3d93ca-9139-45f6-b5f3-0c7ba38dd5dd 61 fields · synced Jul 30, 2026
- EUDAMED 11b72c22-168f-4704-a2ce-55c43fae09fd 61 fields · synced May 11, 2026