FoamFit
by Pearl Technology AG 2 variants
Ref 1238-A
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 | Number764017806FoamFitK6 07640178061354 | Date3 Sep 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- Withdrawn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
- FoamFit
- Model / Reference
- 1238-A
- Primary DI / UDI-DI
- 07640178061354
- Basic UDI-DI
- 764017806FoamFitK6
- Direct Marketing DI
- 07640178061354
- EMDN Code
- V080302 Patient positioning medical cushions
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CH-MF-000018100
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Pearl Technology AG
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