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Neoprene Knee Sleeve
EUDAMEDClass I (EU MDR)
Ref 520001(M/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 520001(S/UNI/Gray&Silver)Ref 520001(L/UNI/Gray&Silver)Ref 520001(XL/UNI/Gray&Silver)
Identity
- Trade Name
- Neoprene Knee Sleeve 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 EUDAMED520001(M/UNI/Gray&Silver) EUDAMED520001(S/UNI/Gray&Silver) EUDAMED520001(L/UNI/Gray&Silver) EUDAMED520001(XL/UNI/Gray&Silver) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892938396 EUDAMED04719892938402 EUDAMED04719892938389 EUDAMED04719892938419 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
Neoprene Knee Sleeve 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 (4)
- EUDAMED bd3441be-77af-442a-972a-10fe638ad506 61 fields · synced Oct 5, 2026
- EUDAMED 039014d7-0812-4bc2-9bc3-f823e12fb9fa 61 fields · synced May 17, 2026
- EUDAMED 34406d72-70f5-4c8d-9265-b897bdeb40b3 61 fields · synced May 17, 2026
- EUDAMED 99a899f5-a086-46ac-ac1c-b7eaa966710f 61 fields · synced May 18, 2026