Identity
- Trade Name
- Talarmade OA Knee Brace EUDAMED
- Device Name
- Talarmade OA Knee Brace EUDAMED
- Model / Reference
- 184-00500200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01220000532014 EUDAMED
- Basic UDI-DI
- 12200005318400500BD EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Talarmade OA Knee Brace by Span Link International 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 | 12200005318400500BD | Class I | Active |
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Manufacturer
- Manufacturer
- Span Link International, LLC
- EUDAMED SRN
- US-MF-000012261
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6f3909fe-360f-455f-8bfc-0f7440b39783 61 fields · synced Jun 18, 2026