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3.5 PentaLock Prox. Hum. Plate XL, 7H, L
EUDAMEDClass IIb (EU MDR)
Ref P-4031.05
by Medartis AG
Identity
- Trade Name
- 3.5 PentaLock Prox. Hum. Plate XL, 7H, L EUDAMED
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED
- Model / Reference
- P-4031.05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630894821462 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
Category: Orthopaedic fixation plate, non-bioabsorbable
3.5 PentaLock Prox. Hum. Plate XL, 7H, L 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 | 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 a5ca9c93-0bd4-4cac-b1d1-929bec3f3bda 61 fields · synced Jul 17, 2026