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Kids Orthotics
EUDAMEDClass I (EU MDR)
Ref 640011(17UNI/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 etc
Identity
- Trade Name
- Kids Orthotics 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 EUDAMED640011(17UNI/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964465980 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
Kids Orthotics 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 (1)
- EUDAMED 72997c9f-b37f-471b-9575-d583402f5cf6 61 fields · synced Jun 18, 2026