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Biphasic Plate DF Left
EUDAMEDClass IIb (EU MDR)
Ref 100.178Model Biphasic Plate DF Left
by 41medical AG
Identity
- Trade Name
- Biphasic Plate DF Left EUDAMED
- Device Name
- Biphasic Plate DF EUDAMED
- Model / Reference
- 100.178 EUDAMEDBiphasic Plate DF Left EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640185670419 EUDAMED
- Basic UDI-DI
- 764018567000013JL EUDAMEDB-07640185670419 EUDAMED
- Direct Marketing DI
- 07640185670419 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Biphasic Plate DF Left by 41medical AG — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 764018567000013JL | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 764018567000013JL | Class IIb | Active |
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Manufacturer
- Manufacturer
- 41medical AG
- EUDAMED SRN
- CH-MF-000016966
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (2)
- EUDAMED 2540061c-2f65-4358-8c45-ca3894085898 61 fields · synced Aug 3, 2026
- EUDAMED 1c0cbdc2-04c9-44ba-b703-f859fe86d998 61 fields · synced Aug 3, 2026