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3.5 PentaLock Prox.Hum. Plate XL, 10H, R
EUDAMEDClass IIb (EU MDR)
Ref P-4031.08
by Medartis AG
Identity
- Trade Name
- 3.5 PentaLock Prox.Hum. Plate XL, 10H, R EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- P-4031.08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630894821493 EUDAMED
- Basic UDI-DI
- 76300378020P6 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER 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
3.5 PentaLock Prox.Hum. Plate XL, 10H, R 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 | 76300378020P6 | 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 9e348f2e-d348-4cce-92f9-2fa216de1124 61 fields · synced Jul 13, 2026