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MB-ADJUST Transfemoral
EUDAMEDClass I (EU MDR)
Ref 92-AH10-00UModel MB TF Adjust HD
Identity
- Device Name
- MB-ADJUST Transfemoral EUDAMED
- Model / Reference
- MB TF Adjust HD EUDAMED92-AH10-00U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860013533557 EUDAMED
- Basic UDI-DI
- 0860013533592-AH10-00UXY EUDAMED
- EMDN Code
- P09088099 HIP PROSTHESES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
MB-ADJUST Transfemoral by Martin Bionics Innovations, LLC — Class I — 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 | 0860013533592-AH10-00UXY | Class I | Active |
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Manufacturer
- Manufacturer
- Martin Bionics Innovations, LLC
- EUDAMED SRN
- US-MF-000047184
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 5a2450d0-642a-4bde-9c2a-50e352345c14 61 fields · synced Jun 19, 2026