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MB-ADJUST - Bikini Socket
EUDAMEDClass I (EU MDR)
Ref 92-HK00-00UModel MB Bikini Adjust Kit
Identity
- Device Name
- MB-ADJUST - Bikini Socket EUDAMED
- Model / Reference
- MB Bikini Adjust Kit EUDAMED92-HK00-00U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860013533533 EUDAMED
- Basic UDI-DI
- 0860013533592-HK00-00U5E 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 - Bikini Socket 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-HK00-00U5E | 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 4b5b00aa-543e-4472-ad35-21639091c27f 61 fields · synced Jul 9, 2026