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MB-ADJUST Transtibial
EUDAMEDClass I (EU MDR)
Ref 92-BH00-00U MBModel MB TT AdjustRef 92-YH00-00U MBModel MB TF Adjust Symes
Identity
- Device Name
- MB-ADJUST Transtibial EUDAMED
- Model / Reference
- MB TT Adjust EUDAMED92-BH00-00U MB EUDAMEDMB TF Adjust Symes EUDAMED92-YH00-00U MB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860013533502 EUDAMED00860013533564 EUDAMED
- Basic UDI-DI
- 0860013533592-BH00-00UY6 EUDAMED0860013533592-YH00-00UDW 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 Transtibial 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-BH00-00UY6 | 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 (2)
- EUDAMED 9c9311f7-75ba-4849-b24c-545b12a5033e 61 fields · synced Jul 9, 2026
- EUDAMED 30520d65-6e1f-4fe8-819d-e32ab4c9df44 61 fields · synced May 18, 2026