Profence Nitrile Biod 350
by Hartalega NGC Sdn. Bhd. EUDAMED
Active
Ref L, S, XS, XLModel Biodegradable Nitrile Powder Free Examination Gloves
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955100777HNGCTFMD004XC | Date21 Feb 2025 | 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- Withdrawn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
- Biodegradable Nitrile Examination Gloves
- Model / Reference
- Biodegradable Nitrile Powder Free Examination Gloves, L, S, XS, XL
- Primary DI / UDI-DI
- 09551007779334, 09551007779310, 09551007779303, 09551007779341
- Basic UDI-DI
- 955100777HNGCTFMD004XC
- Unit of Use DI
- 09551007779402, 09551007779389, 09551007779372, 09551007779419
- EMDN Code
- T01020204 Nitrile examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- MY-MF-000010459
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega Ngc 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