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Patella Tracker
EUDAMEDClass I (EU MDR)
Ref 520014(M/Right/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 520014(2XL/Right/Black)Ref 520014(XL/Right/Black)Ref 520014(S/Right/Black)Ref 520014(XL/Left/Black)
Identity
- Trade Name
- Patella Tracker 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 EUDAMED520014(M/Right/Black) EUDAMED520014(2XL/Right/Black) EUDAMED520014(XL/Right/Black) EUDAMED520014(S/Right/Black) EUDAMED520014(XL/Left/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964463191 EUDAMED04719964464518 EUDAMED04719964464495 EUDAMED04719964464297 EUDAMED04719964464488 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
Patella Tracker 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 cbed0f5a-28ac-439d-84a3-1aae7924c93f 61 fields · synced Oct 6, 2026
- EUDAMED 714faf16-b471-4ee7-9ceb-139ec630e1cc 61 fields · synced May 17, 2026
- EUDAMED 53fd31dd-e2f5-4a28-89bf-9e3da025fc75 61 fields · synced May 17, 2026
- EUDAMED 14425970-818c-4de0-b194-7e23bac170b0 61 fields · synced May 19, 2026
- EUDAMED 2e1d7f62-37c4-4ba9-815a-d6eb1b625fe5 61 fields · synced May 19, 2026