Prontex
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref 12964, 12966, 12981, 12982
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760100000F5 | Date30 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Latex Examination Powdered GloveNitrile Examination Powder Free Gloves
- Model / Reference
- 12964, 12966, 12981, 12982
- Primary DI / UDI-DI
- 09551004352943, 09551004352950, 09551004353049, 09551004353056
- Basic UDI-DI
- 955760100000F5, 955760101940H5
- EMDN Code
- T010201, T01020204
- Device Class
- Class I
- Market of Registration
- Italy
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 (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