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WellKnit Knee Brace
EUDAMEDClass I (EU MDR)
Ref 524001(XL/UNI/Black)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 524001(M/UNI/Black)Ref 524001(S/UNI/Black)
Identity
- Trade Name
- WellKnit 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 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 EUDAMED524001(XL/UNI/Black) EUDAMED524001(M/UNI/Black) EUDAMED524001(S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892932400 EUDAMED04719892932417 EUDAMED04719892932424 EUDAMED
- Basic UDI-DI
- 47198728652WK EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
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
WellKnit Knee Brace 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 (3)
- EUDAMED ff5944e7-5fbc-4565-8548-2025db2bbb8c 61 fields · synced Oct 6, 2026
- EUDAMED b9752054-691d-4490-83ca-799b8a0e4dda 61 fields · synced May 19, 2026
- EUDAMED dd8d4c06-b0a3-473d-8914-d1700e912c1b 61 fields · synced May 19, 2026