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Full Length Cushioning Insole
EUDAMEDClass I (EU MDR)
Ref 640009(L/XL/UNI/Black)Model Full Length Insole:640001 Heel Cup Central Spur:640004 Heel Cushion With Removable Pad:640006 “U” Shaped Heel Cushion:640008 Full Length Cushioning Insole:640009 3/4 Arch Support:640010 3/5 Arch Support:640010 etcRef 640009(S/M/UNI/Black)
Identity
- Trade Name
- Full Length Cushioning Insole EUDAMED
- Device Name
- Insole (Orthotic insole) EUDAMED
- Model / Reference
- Full Length Insole:640001 Heel Cup Central Spur:640004 Heel Cushion With Removable Pad:640006 “U” Shaped Heel Cushion:640008 Full Length Cushioning Insole:640009 3/4 Arch Support:640010 3/5 Arch Support:640010 etc EUDAMED640009(L/XL/UNI/Black) EUDAMED640009(S/M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465935 EUDAMED04719964465928 EUDAMED
- Basic UDI-DI
- 47199644664WQ EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Full Length Cushioning Insole 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 | 47199644664WQ | 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 (2)
- EUDAMED bc525284-9403-4e6a-870c-fa62a4fe678c 61 fields · synced Oct 6, 2026
- EUDAMED cc7b71ae-b9b2-4021-9d4a-477c389226b4 61 fields · synced May 17, 2026