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Post Op Shoes
EUDAMEDClass I (EU MDR)
Ref FT009Model FT001,FTO02,FTO03,FT004,FT005,FT006, FT007,FTO08,FTO09,FT010,FT011,FT012
Identity
- Device Name
- Post Op Shoes EUDAMED
- Model / Reference
- FT001,FTO02,FTO03,FT004,FT005,FT006, FT007,FTO08,FTO09,FT010,FT011,FT012 EUDAMEDFT009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200102261 EUDAMED
- Basic UDI-DI
- 697620010POS001DL EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Post Op Shoes by Xiamen Ortocare Sports Health 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 | 697620010POS001DL | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 857d6cda-cf34-4d9d-9a7a-f076e1049c50 61 fields · synced Jun 18, 2026