Favorit Soft Pink Nitril
by Top Glove Sdn. Bhd. EUDAMED
Active
Ref 23534
Overview
Our FAVORIT SOFT PINK NITRIL medical device is designed for safe and comfortable examination of human tissue. This sterilized glove is available in various sizes, making it suitable for a wide range of applications. With its easy-grip texture and hypoallergenic material, our FAVORIT SOFT PINK NITRIL gloves are perfect for healthcare professionals.
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- Withdrawn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
- 23534
- Primary DI / UDI-DI
- 09551004306038
- Basic UDI-DI
- 955760101940H5
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Germany
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