Espeon
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref 100015, 100011, 100007, 100013, 100012, 100008
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955760100560GG | Date29 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Latex Examination Polymer Powder Free GlovesNitrile Examination Powder Free Gloves
- Model / Reference
- 100015, 100011, 100007, 100013, 100012, 100008
- Primary DI / UDI-DI
- 09551004290160, 09551004290269, 09551004290245, 09551004290146, 09551004290139, 09551004290252
- Basic UDI-DI
- 955760100560GG, 955760101940H5
- Direct Marketing DI
- 095510042901600955100429026909551004290245095510042901460955100429013909551004290252
- EMDN Code
- T010201, T01020204
- Device Class
- Class I
- Market of Registration
- Czechia
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