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Full Length Insole
EUDAMEDClass I (EU MDR)
Ref 640001(L/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 etcRef 640001(2XL/UNI/White)Ref 640001(XL/UNI/White)Ref 640001(3XL/UNI/White)Ref 640001(XS/UNI/White)
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(L/UNI/White) EUDAMED640001(2XL/UNI/White) EUDAMED640001(XL/UNI/White) EUDAMED640001(3XL/UNI/White) EUDAMED640001(XS/UNI/White) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872866558 EUDAMED04719892932295 EUDAMED04719872866589 EUDAMED04719892932301 EUDAMED04719872866596 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 (5)
- EUDAMED 64e322f6-c403-4750-9c0e-e6add786e786 61 fields · synced Oct 6, 2026
- EUDAMED e1a3f728-9e15-4c0b-a956-62e835ab80ac 61 fields · synced May 16, 2026
- EUDAMED 992923c4-da62-4d60-b63f-a4a136673efe 61 fields · synced May 17, 2026
- EUDAMED 0309956e-c616-4ac2-b9f6-ccfd1711d635 61 fields · synced May 17, 2026
- EUDAMED 56bf3c93-f1a9-4aa8-8c9b-a9fc62b3b9bd 61 fields · synced May 18, 2026