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Foot Care Product
EUDAMEDClass I (EU MDR)
Ref Gel pad bunion sleeves SModel 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
Identity
- Device Name
- Foot Care Product EUDAMED
- Model / Reference
- 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 EUDAMEDGel pad bunion sleeves S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810167940015 EUDAMED
- Basic UDI-DI
- 081016794FCP001U9 EUDAMED
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Foot Care Product by B&P Trading Company, LLC — 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 | 081016794FCP001U9 | Class I | Active |
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Manufacturer
- Manufacturer
- B&P Trading Company, LLC
- EUDAMED SRN
- US-MF-000048928
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7359d3a2-e9b9-4ec2-99de-aa0104e22373 61 fields · synced Jul 13, 2026