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Knee Ligament Defender
EUDAMEDClass I (EU MDR)
Ref 527003(S/Right/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 527003(L/Left/Black)Ref 527003(L/Right/Black)Ref 527003(M/Left/Black)Ref 527003(XL/Right/Black)
Identity
- Trade Name
- Knee Ligament Defender 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 EUDAMED527003(S/Right/Black) EUDAMED527003(L/Left/Black) EUDAMED527003(L/Right/Black) EUDAMED527003(M/Left/Black) EUDAMED527003(XL/Right/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892939126 EUDAMED04719892939072 EUDAMED04719892939089 EUDAMED04719892939096 EUDAMED04719892939140 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
Knee Ligament Defender 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 c9ac994d-5318-4af4-83fc-a6d452b992e2 61 fields · synced Oct 6, 2026
- EUDAMED 97d05674-9ae3-4926-9f90-64babcfb66aa 61 fields · synced May 16, 2026
- EUDAMED 799233db-05dd-4be4-ab0e-b978384d44a5 61 fields · synced May 16, 2026
- EUDAMED a48011e7-356e-484b-9614-eba370c94368 61 fields · synced May 17, 2026
- EUDAMED c590d2d3-646a-4b69-b5f3-ac485e57fb4f 61 fields · synced May 19, 2026