Iskio Bm
by Winncare France 66 variants
Ref 17.17134BModel CVE
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number366489702653JC 03664604057784 | Date28 Apr 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- Withdrawn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
- Coussins PRIMA FORM, PRIMA PLOT, KALLI VISCO, KALLI DOS VISCO, ISKIO BM, ISKIO VISCO
- Model / reference
- CVE, 17.17134B
- Primary DI / UDI-DI
- 03664604057784
- Basic UDI-DI
- 366489702653JC
- EMDN code
- V08030102 Non-active anti-decubitus medical cushions
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000482
Other devices from Winncare France
Properties
Other properties (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No