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Spiral Knee Support
EUDAMEDClass I (EU MDR)
Ref 2030-BG-L-1Ref 2030-BG-M-1Ref 2030-BG-S-1
Identity
- Trade Name
- Spiral Knee Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 2030-BG-L-1 EUDAMED2030-BG-M-1 EUDAMED2030-BG-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863691473 EUDAMED04719863691466 EUDAMED04719863691459 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Spiral Knee Support by OPPO Medical Corp. — 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 | 471986369CL102DF | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED aac40226-c6ab-4b11-8b7a-3202f6e26c3c 61 fields · synced Oct 6, 2026
- EUDAMED e36cb951-13d3-4719-859b-03ece3f1a1e6 61 fields · synced May 16, 2026
- EUDAMED 174ba6f6-ba14-4985-8e24-4c4eacd3e4fc 61 fields · synced May 18, 2026