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Functional Knee Brace
EUDAMEDClass I (EU MDR)
Ref 527001(XL/Right/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 520012(XL/UNI/Black)Ref 520012(L/UNI/Black)Ref 520012(M/UNI/Black)
Identity
- Trade Name
- Functional Knee Brace EUDAMEDKnee Wrap Stabilizer 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 EUDAMED527001(XL/Right/Black) EUDAMED520012(XL/UNI/Black) EUDAMED520012(L/UNI/Black) EUDAMED520012(M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938211 EUDAMED04719964463832 EUDAMED04719964463719 EUDAMED04719964463702 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDGreece 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 (4)
- EUDAMED dea80aad-67d0-4b9b-9983-75e928205cac 61 fields · synced Oct 6, 2026
- EUDAMED 962d85c5-848a-42d6-a606-9187bea9523a 61 fields · synced May 16, 2026
- EUDAMED d578f778-2980-46d5-abab-4fe60db038be 61 fields · synced May 17, 2026
- EUDAMED 577df453-ee0f-4904-9285-09e9a8b37ed7 61 fields · synced May 18, 2026