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Full Length Insole
EUDAMEDClass I (EU MDR)
Ref 640001(S/UNI/White)Model “U” Shaped Heel Cushion:640008 3/4 Arch Support:640010 3/5 Arch Support:640010 3/6 Arch Support:640010 3/7 Arch Support:640010 Full Length Cushioning Insole:640009 Full Length Insole:640001 Heel Cup Central Spur:640004 etc
Identity
- Trade Name
- Full Length Insole EUDAMED
- Device Name
- Insole (Orthotic insole) EUDAMED
- Model / Reference
- “U” Shaped Heel Cushion:640008 3/4 Arch Support:640010 3/5 Arch Support:640010 3/6 Arch Support:640010 3/7 Arch Support:640010 Full Length Cushioning Insole:640009 Full Length Insole:640001 Heel Cup Central Spur:640004 etc EUDAMED640001(S/UNI/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872866572 EUDAMED
- Basic UDI-DI
- 47198728664WS EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Full Length Insole by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 47198728664WS | Class I | Active |
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Manufacturer
- Manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000011447
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c8d80099-7edc-435c-9929-6eb6c8fec425 61 fields · synced Jun 20, 2026