aximed pro Nitril
by Bingold GmbH + Co. KG 6 variants
Ref 1130063, 1130061, 1130054, 1130066, 1130062, 1130067, 1130052, 1130058, 1130053, 1130065, 1130057
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- Withdrawn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 35PLUS
- Model / Reference
- 1130063, 1130061, 1130054, 1130066, 1130062, 1130067, 1130052, 1130058, 1130053, 1130065, 1130057
- Primary DI / UDI-DI
- 04004034001145, 04004034001107, 04004034000889, 04004034001046, 04004034001121, 04004034001060, 04004034000841, 04004034000964, 04004034000865, 04004034001022, 04004034000940
- Basic UDI-DI
- 4004034NOC35GZ
- Unit of Use DI
- 04004034002746, 04004034002722, 04004034002692, 04004034002777, 04004034002739, 04004034002784, 04004034002678, 04004034002814, 04004034002685, 04004034002760, 04004034002807
- 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