Identity
- Device Name
- UNIV KNEE WRAP - OPN PAT EUDAMED
- Model / Reference
- 8653BLAUN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05028318360802 EUDAMED
- Basic UDI-DI
- 7631898653DA EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Univ Knee Wrap - Opn Pat by Elastic Therapy — 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 | 7631898653DA | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 8f0cb0c4-4698-4441-8570-e702ae36a1a6 61 fields · synced Jun 18, 2026