Dermagrip Sterile
by WRP Asia Pacific Sdn. Bhd. Malaysia EUDAMED
Ref D1504-13
EMDN T010201
Overview
Discover the Dermagrip Sterile, a reliable and efficient hand examination glove made from natural rubber latex. This sterile device features a trade name of DERMAGRIP STERILE, is implantable with no sutures required, and has a risk classification ID of -203. Developed by Remesco Handelsges.m.b.H, this product is suitable for use in various medical settings. With its self-testing capability, it also meets the standards for single-use medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9557795LTX-EG02NA | Date8 Jan 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Natural Rubber Latex Examination Gloves, Powder Free, Sterile
- Model / Reference
- D1504-13
- Primary DI / UDI-DI
- 09557795013742
- Basic UDI-DI
- 9557795LTX-EG02NA
- EMDN Code
- T010201 Latex examination / treatment gloves
- Device Class
- Class I
- 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 (11)
- 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
Sources (1)
- EUDAMED 1a631299-d9fd-4a5a-a8a3-314610f093e0