EU Manufacturer
🇰🇷 South Korea
Active
GB Lifecare Co., Ltd.
SRN: KR-MF-000039508
·
Gwangwol-gil, Okgu-eup 28-5, 54172 Gunsan-si, Jeollabuk-do, South Korea
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- Gwangwol-gil, Okgu-eup 28-5, 54172 Gunsan-si, Jeollabuk-do, South Korea
- [email protected]
- Phone
- +82 63 453 1421
- Website
- www.philosys.com
Regulatory Overview
Regulation
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Eu Ivdd
2
Classification
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Eu Ivd Annex 2 List B
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL60145538 | TÜV Rheinland LGA Products GmbH | Feb 08, 2024 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
🇬🇷 Greece
🇪🇸 Spain
🇵🇱 Poland
🇷🇴 Romania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Gmate® Blood Glucose Test Strips | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Gmate® Origin | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |