General Life Biotechnology Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED FDA SRN TW-MF-000027109 FEI 3008877272
- Devices
- 192
- Registrations
- EUDAMED·FDA
- FDA recalls
- 0
DeviceDevice · Authorizations Verified Status Regime Registry Class
Microlife Multiplex Total Cholesterol Test Strip Ref TCS700-14
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Prime Uric Acid Control Solution Ref BXM010-CSU11-PTM
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Multiplex Uric Acid Control Solution Ref UACS700-0
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Total Cholesterol Test Strip Ref BK-SC2-10V
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Multi-Monitoring Meter Ref BX-M040-B
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Glucose Test Strip Ref BK-SG1-50V
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMedidor de monitoreo múltiple Multiple Ref BX-M060
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BMicrolife Multiplex Total Cholesterol Test Strip Ref TCS700-15
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Insulini Glucose Control Solution Ref BGCS701-1
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Glucose Test Strip Ref BK-SG1-10V
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Prime Glucose Control Solution Ref BXM010-CSG50-PTM
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Multiplex Glucose Test Strip Ref BGS700-255
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CfamilyDr. III Glucose Control Solution Ref BXM04D-CSG52-FDR
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Multi-Monitoring Meter Ref BX-M00D-B
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CfamilyDr. II Total Cholesterol Control Solution Ref BXM04D-CSC22-FDR
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CfamilyDr. Uric Acid Control Solution Ref BXM04D-CSU12-FDR
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Uric Acid Test Strip Ref BK-SU1-25F
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Multiplex Glucose Test Strip Ref BGS700-256
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Multi-Monitoring Meter Ref BX-M010-B
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Supreme Multi-Monitoring Meter Ref BX-M02D-B
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Insulini Uric Acid Control Solution Ref UACS701-1
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CMicrolife Multiplex Total Cholesterol Control Solution Ref TCCS700-2
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:CBeneCheck Multi-Monitoring System Ref BK3-12M-D
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck II Glucose Control Solution Ref BK-CSG30
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BMicrolife Multiplex Multi-Monitoring System Ref BX-M06D
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Multi-Monitoring System Ref BK6-10M
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Uric Acid Control Solution Ref PD-F007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Uni Premium Harnsäure-Messsystem Ref BSU010
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Plus pro Glucose Monitoring System Ref BKM21-2-B
Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Uric Acid Control Solution Ref BK-CSU11
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Uric Acid Control Solution Ref BK-CSU12
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingSANcheck ABEL β-Ketone Test Strip Ref BK-SK1
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testing- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
Uric acid monitoring system Ref BSU020
Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED ClassClass:IVD for self-testingGlb Benecheck Premium Glu Monitoring System Ref K123090
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIBeneCheck II Total Cholesterol Control Solution Ref BK-CSC21
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Uni Hemoglobin Monitoring System Ref BSH010
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Uric Acid Control Solution Ref PD-F008
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testing- Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED ClassClass:IVD Annex II List B
BeneCheck Supreme Multi-Monitoring System Ref BX-M00D
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Total Cholesterol Control Solution Ref PD-F011
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Multi-Monitoring System Ref BK3-12M
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Supreme Glucose Test Strip Ref BK-SG1
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Uric Acid Control Solution Ref PD-F006
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Uric Acid Test Strip Ref BK-U1
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck Hb Hemoglobin Control Solution Ref BK-CSH32
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingBeneCheck II Total Cholesterol Control Solution Ref BK-CSC22
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD for self-testingMicrolife Multiplex Multi-Monitoring System Ref BX-M060
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Uni Blood Glucose Monitoring System Ref BSG010-2
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BBeneCheck Multi-Monitoring System Ref BK1-10M-2
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
Rows 101-150 of 192
Showing 101-150 of 192
Company details
- EUDAMED SRN
- TW-MF-000027109
- FDA FEI number
- 3008877272
- EU VAT number
- 16779618
- EUDAMED status
- Active
- EUDAMED registered name
- General Life Biotechnology Co., Ltd.
- EUDAMED abbreviated name
- General Life Biotechnology
- Registered address
- 6, 7F., No. 669, Jhongjheng Rd., 242, New Taipei City, Taiwan
- Website
- www.glbiotech.com.tw/
- [email protected]
- Phone
- +886-2-2205-3698
- PRRC contact
- Mary Hu(public in EUDAMED)
EUDAMED certificates2
2 certificates·2 valid, 0 expired·IVDR 2·next expiry 18 Aug 2030
TÜV Rheinland LGA Products GmbH 0197 ·2 certificates
- HX 2029595-1 Restricted
Quality management system ·EU IVDR
- Issued
- 11 Sep 2026
- Expires
- 18 Aug 2030
- Reason
- Other
- IX 2029595-1 Active Supplemented
Technical documentation ·EU IVDR
- Issued
- 11 Sep 2026
- Expires
- 18 Aug 2030
- Reason
- Add device or group
Related companies
Authorised representatives
- MDSS GmbH DE