Sugentech, Inc.

South Korea KR-MF-000023952 Last updated 23 Oct 2026

Is this your brand? Sign in to claim this brand

Devices: 17
Registries: EUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue17

SLHR020E Ref SLHR020E

Class B EUDAMED Active
ALIB012E Ref ALIB012E

IVD General EUDAMED Active
ALIB024E Ref ALIB024E

IVD General EUDAMED Active
SLHR010E Ref SLHR010E

Class B EUDAMED Active
ALFB012E Ref ALFB012E

IVD General EUDAMED Active
ALIB012EH Ref ALIB012EH

IVD General EUDAMED Active
ALFB024EH Ref ALFB024EH

IVD General EUDAMED Active
SBPD001E Ref SBPD001E

Class A EUDAMED Active
ALFB012EH Ref ALFB012EH

IVD General EUDAMED Active
SLHR003E Ref SLHR003E

Class B EUDAMED Active
ALFB024E Ref ALFB024E

IVD General EUDAMED Active
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Ref K142754

Class II FDA 510(k) Active
IFFD001E Ref IFFD001E

Class A EUDAMED Active
SBFD001E Ref SBFD001E

Class A EUDAMED Active
SEYD001E Ref SEYD001E

Class A EUDAMED Active
CT05100E Ref CT05100E

Class A EUDAMED Active
SBTD001E Ref SBTD001E

Class A EUDAMED Active
SEPD001E Ref SEPD001E

Class A EUDAMED Active
CT10300E Ref CT10300E

Class A EUDAMED Active

EUDAMED certificates4

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Eurofins Electric & Electronics Finland Oy 0537 2 certificates

CR-04-1273-918-26 Issued

Quality management system EU IVDR

Issued
12 Aug 2026

Expires
20 Jan 2030
CR-04-1273-919-26 Issued

Technical documentation EU IVDR

Issued
12 Aug 2026

Expires
20 Jan 2030

TÜV SÜD Product Service GmbH 0123 2 certificates

V10 002704 0024 Withdrawn

Quality management system EU IVDR

Issued
21 Jan 2025

Expires
20 Jan 2030

Reason
Transferred to other nb
V74 002704 0025 Withdrawn

Technical documentation EU IVDR

Issued
24 Jan 2025

Expires
20 Jan 2030

Reason
Transferred to other nb

Authorised representatives

Medical Technology Promedt Consulting GmbH DE

Notified bodies

What Sugentech, Inc. makes

Sugentech, Inc. manufactures pregnancy testing devices, including lateral flow test strips and digital pregnancy tests for home use. Their portfolio also includes diagnostic devices for infectious disease testing, such as the IFFD001E and SBFD001E, as well as blood glucose monitoring systems like the CT05100E and CT10300E. Additional products include urine test strips for specific medical markers, such as the SBTD001E and SEPD001E.

The company’s devices are classified under EU Class A and Class II categories, with listings in the EUDAQS database (eudamed) and FDA’s 510(k) clearance registry. These products are intended for in vitro diagnostic use and comply with relevant regulatory requirements for their respective markets.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: South Korea
Address: 721-26, Jeongjungyeonje-ro, Cheongju-si, South Korea
Website: sugentech.com
Email: [email protected]
PRRC contact: Sujin Ku
EUDAMED SRN: KR-MF-000023952
FDA FEI number: 3010879605

Catalogue17

SLHR020E Ref SLHR020E

ALIB012E Ref ALIB012E

ALIB024E Ref ALIB024E

SLHR010E Ref SLHR010E

ALFB012E Ref ALFB012E

ALIB012EH Ref ALIB012EH

ALFB024EH Ref ALFB024EH

SBPD001E Ref SBPD001E

ALFB012EH Ref ALFB012EH

SLHR003E Ref SLHR003E

ALFB024E Ref ALFB024E

Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Ref K142754

IFFD001E Ref IFFD001E

SBFD001E Ref SBFD001E

SEYD001E Ref SEYD001E

CT05100E Ref CT05100E

SBTD001E Ref SBTD001E

SEPD001E Ref SEPD001E

CT10300E Ref CT10300E