Epic N
by WRP Asia Pacific Sdn. Bhd. Malaysia EUDAMED
Ref EP-13-55
EMDN T01010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9557795NBR-SG01EG | Date22 Nov 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Nitrile Surgical Gloves, Powder Free, Sterile
- Model / Reference
- EP-13-55
- Primary DI / UDI-DI
- 09557795000605
- Basic UDI-DI
- 9557795NBR-SG01EG
- EMDN Code
- T01010202 Nitrile surgical gloves
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- MY-MF-000004690
- Authorised representative
- REMESCO HANDELSGESMBH AT-AR-000002669
Other devices from WRP Asia Pacific Sdn. Bhd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 162f71a1-81e9-4372-9cbf-b59ffa23516f