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Pencilbone Compr. Pl 8Hole Bar 09mm, t1.0
EUDAMEDClass IIb (EU MDR)
Ref M2-4392Ref M2-4392S
by Medartis AG
Identity
- Trade Name
- Pencilbone Compr. Pl 8Hole Bar 09mm,t1.0 EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- M2-4392 EUDAMEDM2-4392S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630037859802 EUDAMED07630037861775 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
Pencilbone Compr. Pl 8Hole Bar 09mm, 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 edf2c31f-be7a-442f-a9d9-31c701a6a4e5 61 fields · synced Aug 2, 2026
- EUDAMED dfc81c40-02fe-4360-8b88-3ddd72311eb0 61 fields · synced May 18, 2026