← Back to catalogue
Knee Wrap Stabilizer
EUDAMEDClass I (EU MDR)
Ref 520012(S/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 520012(L/UNI/Black)Ref 520012(XL/UNI/Black)
Identity
- Trade Name
- Knee 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 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 EUDAMED520012(S/UNI/Black) EUDAMED520012(L/UNI/Black) EUDAMED520012(XL/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872869238 EUDAMED04719872869320 EUDAMED04719872869443 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 Wrap Stabilizer 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED e274f39e-9565-4dbb-82a3-f7b2e957bfa8 61 fields · synced Oct 6, 2026
- EUDAMED 3fe0cda9-17b1-46d1-b428-c15feb7625bf 61 fields · synced May 17, 2026
- EUDAMED aa7e3a61-6233-42bc-a8d3-da95c28e7534 61 fields · synced May 19, 2026