Batex
by Top Glove Sdn. Bhd. Malaysia EUDAMED
Ref NR. 586.48
EMDN T01020204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760101940H5 | Date17 Feb 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Nitrile Examination Powder Free Gloves
- Model / Reference
- NR. 586.48
- Primary DI / UDI-DI
- 09551004301163
- Basic UDI-DI
- 955760101940H5
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Norway
Manufacturer details
- EUDAMED SRN
- MY-MF-000009690
- Authorised representative
- Ulma International GmbH DE-AR-000010015
Other devices from Top Glove Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 09551004301163|955760101940H5