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Functional Knee Brace
EUDAMEDClass I (EU MDR)
Ref 527002(S/Right/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 527001(XL/Left/Black)Ref 527001(L/Right/Black)Ref 527002(M/Left/Black)Ref 527001(L/Left/Black)Ref 527002(S/Left/Black)Ref 527002(L/Left/Black)Ref 527002(XL/Left/Black)Ref 527001(M/Left/Black)
Identity
- Trade Name
- Functional Knee Brace EUDAMED
- Device Name
- Functional Knee Brace, Knee Brace, OA Knee Brace, Post-OP Brace (Knee support orthosis) EUDAMED
- Model / Reference
- Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 EUDAMED527002(S/Right/Black) EUDAMED527001(XL/Left/Black) EUDAMED527001(L/Right/Black) EUDAMED527002(M/Left/Black) EUDAMED527001(L/Left/Black) EUDAMED527002(S/Left/Black) EUDAMED527002(L/Left/Black) EUDAMED527002(XL/Left/Black) EUDAMED527001(M/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938273 EUDAMED04719892938204 EUDAMED04719892938150 EUDAMED04719892938242 EUDAMED04719892938143 EUDAMED04719892938266 EUDAMED04719892938228 EUDAMED04719892938280 EUDAMED04719892938167 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMEDNetherlands 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
Functional Knee Brace by Orthotech Rehabilitation Co., Ltd. — 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 | 47199644652WH | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED 71df2cf7-b219-40f2-98fa-fa27d66318f2 61 fields · synced Oct 6, 2026
- EUDAMED 7e1e9f02-8bfc-4d09-bd04-140dd1b8e415 61 fields · synced May 16, 2026
- EUDAMED 9c0bd924-a36d-472d-8783-1608534617b1 61 fields · synced May 17, 2026
- EUDAMED 4b68f32a-3b9d-42fb-b1c2-6056bc43cd42 61 fields · synced May 17, 2026
- EUDAMED addc7a4c-4a83-449d-b8c6-41147b33d07d 61 fields · synced May 17, 2026
- EUDAMED 5510bb8e-571b-4e22-9ed7-28d3811a2ee5 61 fields · synced May 17, 2026
- EUDAMED 96cb2ff6-dc26-4112-8a91-82867a4a972e 61 fields · synced May 19, 2026
- EUDAMED 83a3a136-d103-485e-80b1-f1f20ce59f8e 61 fields · synced May 19, 2026
- EUDAMED 5ace25e0-dc10-4351-8498-d769f225b0fd 61 fields · synced May 19, 2026