Gmate® Control Solution (Normal)
by GB Lifecare Co., Ltd. EUDAMED
Active
Ref PC002-NModel PC-002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880930116PC002N4X | Date29 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
- IX 2061678-1 Issued
Technical documentation EU IVDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 22 Sep 2026
- Expires
- 21 Sep 2031
Specification
- Model / Reference
- PC-002, PC002-N
- Primary DI / UDI-DI
- 08809301168301
- Basic UDI-DI
- 880930116PC002N4X
- EMDN Code
- W010106010801 Blood test strips controls
- Device Class
- Class C
- Market of Registration
- Greece
Manufacturer details
- EUDAMED SRN
- KR-MF-000039508
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from GB Lifecare Co., Ltd.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No