Robemed
by Top Glove Sdn. Bhd. Malaysia EUDAMED
Ref ENW50S/ GELA67
EMDN T010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760100000F5 | Date30 Mar 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Latex Examination Powdered Glove
- Model / Reference
- ENW50S/ GELA67
- Primary DI / UDI-DI
- 09551004310837
- Basic UDI-DI
- 955760100000F5
- EMDN Code
- T010201 Latex examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Spain
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 (12)
- Sterile: No
- Implantable: No
- Reusable: 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 9da52ae7-6385-45fb-87d5-faf1cdeab5f2