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Patellar Tracking Orthosis
EUDAMEDClass I (EU MDR)
Ref 525001(L/Right/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 525001(L/Left/Gray&Silver)Ref 525001(M/Right/Gray&Silver)Ref 525001(M/Left/Gray&Silver)Ref 525001(XL/Left/Gray&Silver)
Identity
- Trade Name
- Patellar Tracking Orthosis 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 EUDAMED525001(L/Right/Gray&Silver) EUDAMED525001(L/Left/Gray&Silver) EUDAMED525001(M/Right/Gray&Silver) EUDAMED525001(M/Left/Gray&Silver) EUDAMED525001(XL/Left/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938310 EUDAMED04719892938303 EUDAMED04719892938334 EUDAMED04719892938327 EUDAMED04719892938365 EUDAMED
- Basic UDI-DI
- 47199644652WH EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Patellar Tracking Orthosis 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 e00f1a8b-a682-4a22-9080-cdd4be3f5a5a 61 fields · synced Oct 6, 2026
- EUDAMED 61e072df-f989-4dc6-917d-17ce26454c78 61 fields · synced May 16, 2026
- EUDAMED bea904d1-59bb-465e-aba9-1f67966197ab 61 fields · synced May 17, 2026
- EUDAMED 2a4ff7e6-aed0-4653-9238-1ba6505b01bb 61 fields · synced May 17, 2026
- EUDAMED 4495435d-d4c8-43cd-8f63-10716673a6e5 61 fields · synced May 18, 2026