Kolibri
by Bingold GmbH + Co. KG 9 variants
Ref 2286483, 2232404, 2232405, 2232415, 2286486, 2232414, 2232409, 2232413
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 | Number4004034NOC35GZ | Date16 Feb 2022 | 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- Withdrawn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
- Nitril 35PLUSNitril 30PLUS
- Model / Reference
- 2286483, 2232404, 2232405, 2232415, 2286486, 2232414, 2232409, 2232413
- Primary DI / UDI-DI
- 04004034008243, 04004034003262, 04004034003293, 04004034005518, 04004034008366, 04004034005488, 04004034002395, 04004034005457
- Basic UDI-DI
- 4004034NOC35GZ, 4004034NOC30GP
- Unit of Use DI
- 04004034008267, 04004034003255, 04004034003286, 04004034005501, 04004034008359, 04004034005471, 04004034002388, 04004034005440
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000016561
Other devices from Bingold GmbH + Co. KG
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