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W-FLITE Knee Brace
EUDAMEDClass I (EU MDR)
Ref 527004(S/Left/Blue)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 527004(S/Right/Blue)Ref 527004(M/Right/Blue)Ref 527004(XL/Right/Blue)Ref 527004(L/Left/Blue)
Identity
- Trade Name
- W-FLITE Knee Brace 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 EUDAMED527004(S/Left/Blue) EUDAMED527004(S/Right/Blue) EUDAMED527004(M/Right/Blue) EUDAMED527004(XL/Right/Blue) EUDAMED527004(L/Left/Blue) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964467144 EUDAMED04719964467151 EUDAMED04719964467175 EUDAMED04719964467199 EUDAMED04719964464815 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
W-FLITE Knee Brace 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 e5eb734f-1650-40d8-93bd-ec1a5ecdd967 61 fields · synced Oct 6, 2026
- EUDAMED 01816e73-6673-4ecb-b67c-b5d570185ffa 61 fields · synced May 17, 2026
- EUDAMED edd6883c-d630-4ff5-92a9-4ac72c9af30a 61 fields · synced May 18, 2026
- EUDAMED 392640bd-c027-4055-ad64-f4b961a5be74 61 fields · synced May 19, 2026
- EUDAMED 69bd44c2-ae85-4739-b190-fe8e491b6fb0 61 fields · synced May 19, 2026