Euroglove-Pcp
by Terang Nusa (Malaysia) Sdn. Bhd.
Ref TNMSD201 – SIZE “7.0” – REF. 90-484-12, TNMSD201 – SIZE “9.0” – REF. 90-484-16, TNMSD201 – SIZE “7.5” – REF. 90-484-13, TNMSD201, TNMSD201 – SIZE “8.0” – REF. 90-484-14, TNMSD201 – SIZE “6.5” – REF. 90-484-11, TNMSD201 – SIZE “5.5” – REF. 90-484-9, TNMSD201 – SIZE “8.5” – REF. 90-484-15, TNMSD201 – SIZE “6.0” – REF. 90-484-10
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955507611160H6 | Date18 Mar 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile Polychloroprene Surgical Powder Free Gloves
- Model / Reference
- TNMSD201 – SIZE “7.0” – REF. 90-484-12, TNMSD201 – SIZE “9.0” – REF. 90-484-16, TNMSD201 – SIZE “7.5” – REF. 90-484-13, TNMSD201, TNMSD201 – SIZE “8.0” – REF. 90-484-14, TNMSD201 – SIZE “6.5” – REF. 90-484-11, TNMSD201 – SIZE “5.5” – REF. 90-484-9, TNMSD201 – SIZE “8.5” – REF. 90-484-15, TNMSD201 – SIZE “6.0” – REF. 90-484-10
- Primary DI / UDI-DI
- 09555076121841, 09555076121889, 09555076121858, 09555076121803, 09555076121865, 09555076121834, 09555076121896, 09555076121810, 09555076121872, 09555076121827
- Basic UDI-DI
- 955507611160H6
- EMDN Code
- T01010201 Polychloropren surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- MY-MF-000023462
- Authorised representative
- Ulma International GmbH DE-AR-000010015
Other devices from Terang Nusa (Malaysia) Sdn. Bhd.
Properties
Other properties (12)
- 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