Euroglove-Nit
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref EB201 – SIZE “S” – REF. 05151, EB201 – SIZE “M” – REF. 05152, EB201 – SIZE “XS” – REF. 05150
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- Withdrawn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
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Nitrile Examination Powder Free Gloves
- Model / Reference
- EB201 – SIZE “S” – REF. 05151, EB201 – SIZE “M” – REF. 05152, EB201 – SIZE “XS” – REF. 05150
- Primary DI / UDI-DI
- 09551004353230, 09551004353247, 09551004353223
- Basic UDI-DI
- 955760101940H5
- EMDN Code
- T01020204 Nitrile 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
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