Disposable infection control barrier
by Minitube AB EUDAMED
Active
Ref 403626, 403627
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B9764000006K | Date15 Dec 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Disposable infection control barrier
- Model / Reference
- 403626, 403627
- Primary DI / UDI-DI
- 07350069421258, 07350069421265
- Basic UDI-DI
- ++B9764000006K
- Secondary DI
- B976403627
- Unit of Use DI
- 07350069420268, 07350069420275
- EMDN Code
- T030102 Cover sheaths, instruments and equipments
- Device Class
- Class I
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000002089
Other devices from Minitube 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