Color Cast Shoe
by Health Nuri Co., Ltd. 4 variants
Ref Not applicableModel 401,CCS-101S, CCS-101M, CCS-101L, CCS-101XL
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880965339CCS401HF 08809303743186 | Date11 Jun 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cast Shoe
- Model / Reference
- 401, CCS-101S, CCS-101M, CCS-101L, CCS-101XL, Not applicable
- Primary DI / UDI-DI
- 08809303743186
- Basic UDI-DI
- 880965339CCS401HF
- EMDN Code
- Y063303 Ready-made orthotic shoes
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000043704
- Authorised representative
- SOAR & PARTNERS Sp. z o.o. PL-AR-000040956
Other devices from Health Nuri Co., Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No