Gmate® Origin Blood Glucose Monitoring System
by GB Lifecare Co., Ltd. 2 variants
Ref PG310-004-25
Active
CE IVDR
Valid until
21 Sep 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880930116PG31000425LM 08809301169988 | Date28 Sep 2026 | StatusActive |
Certificates
- IX 2061678-1 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 22 Sep 2026
- Expires
- 21 Sep 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- PG310-004-25
- Primary DI / UDI-DI
- 08809301169988
- Basic UDI-DI
- 880930116PG31000425LM
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class C
- EU 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 (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No