Bite guard for single use
by FBI Medizintechnik GmbH EUDAMED
Active
Ref BIGU-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42623581500496 | Date4 Feb 2026 | 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- Withdrawn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
- Model / Reference
- BIGU-S
- Primary DI / UDI-DI
- 14262358150049
- Basic UDI-DI
- 42623581500496
- Direct Marketing DI
- 14262358150049
- EMDN Code
- G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000024110
Other devices from FBI Medizintechnik GmbH
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