Bretex Sinus14 310 H3
by Breckle Matratzenwerk Weida 2 variants
Ref Bretex Sinus14 310 H3 100/200
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 | Number40194730024F 04019473487924 | Date12 Apr 2023 | 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- Withdrawn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
- medical mattress
- Model / Reference
- Bretex Sinus14 310 H3 100/200
- Primary DI / UDI-DI
- 04019473487924
- Basic UDI-DI
- 40194730024F
- Direct Marketing DI
- 04019473487924
- EMDN Code
- V080702 Non active anti-decubitus medical mattresses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000010222
Other devices from Breckle Matratzenwerk Weida
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