Clinisafe
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref 01305XL, 01305L, 01305S, 01314S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760101080G4 | Date1 Apr 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- ClinisafeClinisafe Black Nitrile
- Device Name
- Latex Examination Powder Free GloveNitrile Examination Powder Free Gloves
- Model / Reference
- 01305XL, 01305L, 01305S, 01314S
- Primary DI / UDI-DI
- 09551004338664, 09551004338657, 09551004338633, 09551004329334
- Basic UDI-DI
- 955760101080G4, 955760101940H5
- Direct Marketing DI
- 09551004329334
- 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