Super Flex
by Trust Rubber Industry Co., Ltd. EUDAMED
Active
Ref SPLPFL3303, SPLPFXL3304Model Single use device
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88594892000TRN6 | Date29 Dec 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- Withdrawn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
- Latex Powder Free Examination Gloves
- Model / Reference
- Single use device, SPLPFL3303, SPLPFXL3304
- Primary DI / UDI-DI
- 08859489200133, 08859489200140
- Basic UDI-DI
- 88594892000TRN6
- Direct Marketing DI
- 0885948920013308859489200140
- EMDN Code
- T010201 Latex examination / treatment gloves
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TH-MF-000007866
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Trust Rubber Industry Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- 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