Identity
- Device Name
- Prosthetic components for lower limb EUDAMED
- Model / Reference
- 2T16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810053310076 EUDAMED
- Basic UDI-DI
- 081005331medexprosthetiCS EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
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
Prosthetic components for lower limb by Medex International Inc. — 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 | 081005331medexprosthetiCS | Class I | Active |
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Manufacturer
- Manufacturer
- Medex International Inc.
- EUDAMED SRN
- US-MF-000011260
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED ebee7b09-ad8f-438d-ab17-0019f9bc1202 61 fields · synced Jun 18, 2026