GB Lifecare Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000039508
- Devices
- 9
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- Authorised rep.
- Obelis s.a.BE
What GB Lifecare Co., Ltd. makes
GB Lifecare Co., Ltd. manufactures in vitro diagnostic (IVD) devices, including the Gmate® Origin system and Gmate® blood glucose test strips. These products are designed for self-monitoring of blood glucose levels, supporting diabetes management.
The company’s portfolio is classified under IVD Annex II List B devices and is registered in the EU’s eudamed database. The manufacturer is based in South Korea.
Catalogue
Gmate® Plus Blood Glucose Test Strip Ref PS-003-25-2
CE IVDR EUDAMEDGmate® Origin Blood Glucose Monitoring System Ref PG310-003-25
CE IVDR EUDAMEDGmate® Control Solution (Low) Ref PC001-L
CE IVDR EUDAMEDGmate® Origin Blood Glucose Meter Ref PG310
CE IVDR EUDAMEDGmate® Control Solution (Normal) Ref PC002-N
CE IVDR EUDAMEDGmate® Origin Blood Glucose Monitoring System Ref PG310-004-25
CE IVDR EUDAMEDGmate® Control Solution (High) Ref PC003-H
CE IVDR EUDAMEDGmate® Origin Ref PG301-INT
CE IVDD EUDAMEDGmate® Blood Glucose Test Strips Ref PS004-INT
CE IVDR CE IVDD EUDAMED
Company details
- EUDAMED SRN
- KR-MF-000039508
- EU VAT number
- 123-81-88458
- EUDAMED status
- Active
- EUDAMED registered name
- GB Lifecare Co., Ltd.
- Registered address
- 28-5, Gwangwol-gil, Okgu-eup, 54172, Gunsan-si, Jeollabuk-do, South Korea
- Website
- www.philosys.com
- [email protected]
- Phone
- +82 63 453 1421
- PRRC contact
- Mo-Se Park
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 21 Sep 2031
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HX 2061678-1 Issued
Quality management system EU IVDR
- Issued
- 22 Sep 2026
- Expires
- 21 Sep 2031
- IX 2061678-1 Issued
Technical documentation EU IVDR
- Issued
- 22 Sep 2026
- Expires
- 21 Sep 2031
Frequently asked questions
How many devices does GB Lifecare Co., Ltd. have in the registry?
The registry currently lists 9 devices for GB Lifecare Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list GB Lifecare Co., Ltd.'s devices?
Among its 9 most recently registered devices, GB Lifecare Co., Ltd. has devices listed in EUDAMED (9 devices).
What risk classes do GB Lifecare Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for GB Lifecare Co., Ltd.'s devices are IVDR Class C and IVD Annex II List B. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for GB Lifecare Co., Ltd.?
EUDAMED lists 2 certificates for GB Lifecare Co., Ltd. (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 2026-09-22.
What are the newest devices from GB Lifecare Co., Ltd. in the registry?
The most recently registered devices listed for GB Lifecare Co., Ltd. include Gmate® Plus Blood Glucose Test Strip, Gmate® Origin Blood Glucose Monitoring System, Gmate® Control Solution (Low) and Gmate® Origin Blood Glucose Meter.