Microbion
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref GLNI-BLU-S-0002, GLNI-W-XL-0029, GLNI-ORN-M-0033, GLNI-W-XS-0025, GLNI-PNK-L-0010, GLNI-GRN-XL-0017, GLNI-ORN-L-0034, GLNI-BLK-L-0022, GLNI-ORN-S-0032, GLNI-GRN-L-0016, GLNI-BLK-XL-0023, GLNI-ORN-XS-0031, GLNI-PNK-XL-0011, GLNI-W-S-0026, GLNI-GRN-M-0015, GLNI-BLK-M-0021
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760101940H5 | Date17 Feb 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Nitrile Examination Powder Free Gloves
- Model / Reference
- GLNI-BLU-S-0002, GLNI-W-XL-0029, GLNI-ORN-M-0033, GLNI-W-XS-0025, GLNI-PNK-L-0010, GLNI-GRN-XL-0017, GLNI-ORN-L-0034, GLNI-BLK-L-0022, GLNI-ORN-S-0032, GLNI-GRN-L-0016, GLNI-BLK-XL-0023, GLNI-ORN-XS-0031, GLNI-PNK-XL-0011, GLNI-W-S-0026, GLNI-GRN-M-0015, GLNI-BLK-M-0021
- Primary DI / UDI-DI
- 09551004371739, 09551004373061, 09551004372941, 09551004373023, 09551004371951, 09551004371869, 09551004372958, 09551004373153, 09551004372934, 09551004371852, 09551004373160, 09551004372927, 09551004371968, 09551004373030, 09551004371845, 09551004373146
- Basic UDI-DI
- 955760101940H5
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- MY-MF-000009690
- Authorised representative
- Ulma International GmbH DE-AR-000010015
Other devices from Top Glove Sdn. Bhd.
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