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Sd Biosensor

South Korea KR-MF-000009168 Last updated 23 May 2026

Devices
80
Registries
EUDAMEDFDA
FDA recalls
22 ongoing

Catalogue80

Page 1 of 2

Showing 1-50 of 80

EUDAMED certificates6

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

EUDAMED certificates (6)

TÜV SÜD Product Service GmbH 0123 6 certificates

  • V76 075369 0076 Issued

    Technical documentation EU IVDR

    Issued
    15 Jul 2026
    Expires
    14 Jul 2031
  • V76 075369 0075 Issued

    Technical documentation EU IVDR

    Issued
    25 Jun 2026
    Expires
    24 Jun 2031
  • V76 075369 0073 Supplemented

    Technical documentation EU IVDR

    Issued
    29 Sep 2026
    Expires
    2 Feb 2031
    Reason
    Other
  • V76 075369 0071 Issued

    Technical documentation EU IVDR

    Issued
    9 Jul 2025
    Expires
    8 Jul 2030
  • V74 075369 0070 Restricted

    Technical documentation EU IVDR

    Issued
    14 Nov 2025
    Expires
    7 Apr 2030
    Reason
    Product reclassified
  • V13 075369 0072 Supplemented

    Quality management system EU IVDR

    Issued
    25 Mar 2026
    Expires
    16 Mar 2030
    Reason
    Add device or group

Related companies

Notified bodies

FDA recalls2

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2023

    • 31 Mar 2023 Z-1594-2023 Class I Ongoing The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

  • 2022

    • 31 Jan 2022 Z-0719-2022 Class I Ongoing Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Sd Biosensor, Inc. Suwon-si Gyeonggi · KR FEI 3012133212

What Sd Biosensor makes

Sd Biosensor makes glucose monitoring systems for home use, including blood glucose monitoring systems and test strips, as well as lipid profile test strips and analyzers for measuring total cholesterol and other lipids using spectrophotometry or enzyme-based methods.

The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's 510(k) and UDI registries; Sd Biosensor is based in the United States.

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

Frequently asked questions

What does Sd Biosensor make?

Sd Biosensor makes glucose monitoring systems for home use, including blood glucose monitoring systems and test strips, as well as lipid profile test strips and analyzers for measuring total cholesterol and other lipids using spectrophotometry or enzyme-based methods. This is based on the company's summary and the device categories and examples provided, which focus on glucose and lipid testing products for home and clinical use.

Where is Sd Biosensor based?

Sd Biosensor is based in the United States, as stated in the country field and confirmed in the summary section of the device data. This location is explicitly provided and should not be inferred beyond what is given.

Which registries list Sd Biosensor's devices?

Sd Biosensor's devices are listed in the FDA's 510(k) and UDI registries, as indicated in the LISTED IN field and reiterated in the summary. These are the only registries mentioned, and no others should be assumed or added.

How are Sd Biosensor's devices classified?

Sd Biosensor's devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field and the summary. Classification reflects regulatory risk levels, with Class I being lowest risk and Class II requiring more controls, but the company itself is not approved—only individual devices may be authorised.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
South Korea(from SRN)
Address
1556beon-gil, Deogyeong-daero, Gyeonggi-do, Suwon-si, South Korea
Phone
+82 80-970-9700
PRRC contact
KyuHee Lim
EUDAMED SRN
KR-MF-000009168