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Knee Support With Silicone Cushion
EUDAMEDClass I (EU MDR)
Ref 522003(L/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005Ref 522003(S/UNI/Gray&Silver)Ref 522003(XL/UNI/Gray&Silver)Ref 522003(M/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 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 EUDAMED522003(L/UNI/Gray&Silver) EUDAMED522003(S/UNI/Gray&Silver) EUDAMED522003(XL/UNI/Gray&Silver) EUDAMED522003(M/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872864288 EUDAMED04719872864301 EUDAMED04719872864318 EUDAMED04719872864295 EUDAMED
- Basic UDI-DI
- 47198728652WK 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 Zhangpu Ortholife 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 | 47198728652WK | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED ab05ee89-025b-448d-aa37-294c922c13d5 61 fields · synced Oct 6, 2026
- EUDAMED 7ea12494-015b-4850-a2ca-76c7aec6d717 61 fields · synced May 17, 2026
- EUDAMED aa22b331-af6f-4f27-887a-29bb46e7ec9d 61 fields · synced May 18, 2026
- EUDAMED f489ea47-9c47-42d9-b2df-325ed3b55948 61 fields · synced May 19, 2026