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Knee Support With Silicone Cushion
EUDAMEDClass I (EU MDR)
Ref 522003(XL/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 522003(S/UNI/Gray&Silver)Ref 522003(L/UNI/Gray&Silver)
Identity
- Trade Name
- Knee Support With Silicone Cushion 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 EUDAMED522003(XL/UNI/Gray&Silver) EUDAMED522003(S/UNI/Gray&Silver) EUDAMED522003(L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892939065 EUDAMED04719892939058 EUDAMED04719892939034 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Knee Support With Silicone Cushion 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 (3)
- EUDAMED 65416391-3b3c-419d-a96f-f31ed57c5a08 61 fields · synced Oct 6, 2026
- EUDAMED 0cd8460f-0a0f-480a-977b-85672ff2fb40 61 fields · synced May 17, 2026
- EUDAMED 4a79eb40-826b-4913-94c7-0e95a84575e3 61 fields · synced May 17, 2026