Heel spur insoles
by Since Household Care Co., LTD 19 variants
Ref TH08Model SH002/SM163/SH024/ SH021/SW001/SH004/SW002/SM010/SH021/H49/H48/H02/TH09/TH08/TH74/ TH01/TM21/TM46/SM120/SM021/SM059
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 | Number697579554HSI01UE 06975795543466 | Date8 Nov 2023 | 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- Withdrawn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
- Heel spur insoles
- Model / Reference
- SH002/SM163/SH024/ SH021/SW001/SH004/SW002/SM010/SH021/H49/H48/H02/TH09/TH08/TH74/ TH01/TM21/TM46/SM120/SM021/SM059, TH08
- Primary DI / UDI-DI
- 06975795543466
- Basic UDI-DI
- 697579554HSI01UE
- EMDN Code
- V0811 Heel, elbow and knee anti-decubitus protection aids
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000027717
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Since Household Care 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