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PCL Revive
EUDAMEDClass I (EU MDR)
Ref 527005(M/Right/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 527005(XL/Right/Black)Ref 527005(L/Left/Black)Ref 527005(L/Right/Black)Ref 527005(S/Left/Black)
Identity
- Trade Name
- PCL Revive 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 EUDAMED527005(M/Right/Black) EUDAMED527005(XL/Right/Black) EUDAMED527005(L/Left/Black) EUDAMED527005(L/Right/Black) EUDAMED527005(S/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964467373 EUDAMED04719964467410 EUDAMED04719964467380 EUDAMED04719964467397 EUDAMED04719964467342 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
PCL Revive 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 3755fa63-300e-4ab9-88f7-b7f75cf3143f 61 fields · synced Oct 6, 2026
- EUDAMED 1076cc87-d692-4a46-b062-e2164aaef707 61 fields · synced May 17, 2026
- EUDAMED c34822fa-f244-442c-ad87-e55b42ee58e9 61 fields · synced May 17, 2026
- EUDAMED ed08d1b4-b5ab-47c7-8863-39482c9fe876 61 fields · synced May 17, 2026
- EUDAMED 24f06a10-a62b-4fde-b50c-eebf9e164338 61 fields · synced May 18, 2026