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Wrap-around Hinged Knee Support
EUDAMEDClass I (EU MDR)
Ref 520005(2XL/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 DAILY OA KNEE BRACE:525004Ref 520005(M/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 520005(XL/UNI/Gray&Silver)Ref 520005(S/UNI/Gray&Silver)Ref 520005(L/UNI/Gray&Silver)
Identity
- Trade Name
- Wrap-around 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 DAILY OA KNEE BRACE:525004 EUDAMED520005(2XL/UNI/Gray&Silver) EUDAMEDFunctional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 EUDAMED520005(M/UNI/Gray&Silver) EUDAMED520005(XL/UNI/Gray&Silver) EUDAMED520005(S/UNI/Gray&Silver) EUDAMED520005(L/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938587 EUDAMED04719892938556 EUDAMED04719892938570 EUDAMED04719892938563 EUDAMED04719892938549 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Wrap-around 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 |
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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 (5)
- EUDAMED 30917a17-78e4-4818-9ae5-a1036053d9e2 61 fields · synced Oct 7, 2026
- EUDAMED 4fb74e20-140f-4106-9b5a-51d06f3c7807 61 fields · synced May 17, 2026
- EUDAMED 41f89be5-1f42-42a3-8e60-40055984adfd 61 fields · synced May 18, 2026
- EUDAMED a7b6b742-b4b4-4a33-b513-cee905d97249 61 fields · synced May 18, 2026
- EUDAMED 2be78cc1-eacf-492c-a51e-5bfccd0165fa 61 fields · synced May 19, 2026