Foot Care Product
by B&P Trading Company, LLC 4 variants
Ref HT02Model Gel pad bunion sleeves (S/M, L), Night time bunion splints, Gel toe separators (S, M, L), 14-piece bunion kit, Bunion pad & toe spacers, 2-piece sport bunion pad & toe spacer set, Toe spacers for bunions, 2-piece sport bunion toe spacer set, etc
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 | Number081016794FCP001U9 00851081007033 | Date22 Aug 2025 | 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- Withdrawn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
- Foot Care Product
- Model / Reference
- Gel pad bunion sleeves (S/M, L), Night time bunion splints, Gel toe separators (S, M, 14-piece bunion kit, Bunion pad & toe spacers, 2-piece sport bunion pad & toe spacer set, Toe spacers for bunions, 2-piece sport bunion toe spacer set, etc, HT02
- Primary DI / UDI-DI
- 00851081007033
- Basic UDI-DI
- 081016794FCP001U9
- EMDN Code
- Y0999 Personal care aids - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000048928
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from B&P Trading Company, LLC
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