BIOpH+ Footcare
by Biocool AB
Ref BPPFC500EU, BPPFC250EU, BPPFC1250EU
Active
CE MDR
Valid until
5 Oct 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number739205910BPPFCCA | Date24 May 2024 | StatusActive |
Certificates
- 28620160593 Active
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 26 Oct 2023
- Expires
- 5 Oct 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BPPFC500EU, BPPFC250EU, BPPFC1250EU
- Primary DI / UDI-DI
- 07392059101580, 07392059101573, 07392059101597
- Basic UDI-DI
- 739205910BPPFCCA
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class IIa
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000012411
Other devices from Biocool AB
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