← Back to catalogue
Hinged Knee Support
EUDAMEDClass I (EU MDR)
Ref 520004(XL/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 520004(M/UNI/Gray&Silver)Ref 520004(S/UNI/Gray&Silver)Ref 520004(XS/UNI/Gray&Silver)Ref 520004(L/UNI/Gray&Silver)Ref 528003(XL/UNI/Black)Ref 528003(M/UNI/Black)
Identity
- Trade Name
- Hinged Knee Support 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 EUDAMED520004(XL/UNI/Gray&Silver) EUDAMED520004(M/UNI/Gray&Silver) EUDAMED520004(S/UNI/Gray&Silver) EUDAMED520004(XS/UNI/Gray&Silver) EUDAMED520004(L/UNI/Gray&Silver) EUDAMED528003(XL/UNI/Black) EUDAMED528003(M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938532 EUDAMED04719892938518 EUDAMED04719892938525 EUDAMED04719964463139 EUDAMED04719892938501 EUDAMED04719892939317 EUDAMED04719892939294 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Hinged Knee Support 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 3bd8831b-bc41-4dbb-9fe4-28ca5591469f 61 fields · synced Oct 6, 2026
- EUDAMED 56e7f2fa-f469-47c9-8347-7767a96df08b 61 fields · synced May 18, 2026
- EUDAMED 5ad427a4-e424-4657-b573-888c07030e5d 61 fields · synced May 18, 2026
- EUDAMED dfb96ab0-e95b-43db-9c51-6b82f5021944 61 fields · synced May 18, 2026
- EUDAMED eaa14c05-f463-4d6f-9853-85a747e8e73a 61 fields · synced May 18, 2026
- EUDAMED 0bdf91ce-6bfd-4c59-be48-6b19e2470549 61 fields · synced May 19, 2026
- EUDAMED d4e381eb-a91b-4ceb-8a07-8f3ba56382d6 61 fields · synced May 19, 2026