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Sd Biosensor

Active in EUDAMED

Registered as SD Biosensor Inc. (SD Biosensor) in EUDAMED

Also registered as SD Biosensor Inc.

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000009168

Sd Biosensor is a medical device manufacturer based in South Korea, with 80 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class B, C and A; FDA Class II) and 2 FDA recalls as of 13 Nov 2026.

Devices
80
Registrations
EUDAMEDFDA
FDA recalls
22 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 60
  • FDA GUDID 14
  • FDA 510(k) 6

A device listed in two registries counts in both.

Device classes
  • EU Class B 38
  • EU Class C 14
  • FDA Class II 13
  • EU Class A 8
  • FDA Class I 7
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN KR-MF-000009168

At a glance

Counted by deviCERTS from registry records

EU certificates

6 of 6 in force.

See certificates

Market reach

European Union
EUDAMED actor, 6 certificates
United States
FDA establishment, FDA recalls

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue80

Newest first, rows 1-50 of 80

Search and filter all 80 devices
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Rows 1-50 of 80

Showing 1-50 of 80

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000009168
EUDAMED status
Active
EUDAMED registered name
SD Biosensor Inc.
EUDAMED abbreviated name
SD Biosensor
Registered address
1556beon-gil, Deogyeong-daero, 16690, Gyeonggi-do, Suwon-si, South Korea
Phone
+82 80-970-9700
PRRC contact
KyuHee Lim(public in EUDAMED)

EUDAMED certificates6

6 certificates6 valid, 0 expiredIVDR 6next expiry 16 Mar 2030

EUDAMED certificates (6)

TÜV SÜD Product Service GmbH 0123 6 certificates

  • V76 075369 0076 Active

    Technical documentation EU IVDR

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

    Technical documentation EU IVDR

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

    Technical documentation EU IVDR

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

    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 Active Supplemented

    Quality management system EU IVDR

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

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Sd Biosensor, the earliest on 2022-01-31 and the most recent on 2023-03-31. By recorded status: 2 ongoing. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 1
  • 2024 0
  • 2025 0
  • 2026 0

  • 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. Distribution: US Nationwide.

  • 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. Distribution: U.S. Nationwide Distribution

FDA establishments1

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

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

Frequently asked questions

How many devices does Sd Biosensor have in the registry?

The registry currently lists 80 devices for Sd Biosensor. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sd Biosensor's devices?

Among its 50 most recently registered devices, Sd Biosensor has devices listed in EUDAMED (50 devices).

What risk classes do Sd Biosensor's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Sd Biosensor's devices are IVDR Class A, IVDR Class B and IVDR Class C. Each device page shows its own class and authorisation.

Are there FDA recall records for Sd Biosensor?

FDA recall records list 2 recalls initiated by Sd Biosensor, the most recent initiated on 31 Mar 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Sd Biosensor?

EUDAMED lists 6 certificates for Sd Biosensor (technical documentation; quality management system) under IVDR. 3 are recorded with the status issued. The most recent was issued on 29 Sep 2026.

What are the newest devices from Sd Biosensor in the registry?

The most recently registered devices listed for Sd Biosensor include STANDARD™ i FSH, STANDARD™ i LH, STANDARD™ M10 Flu/RSV/SARS-CoV-2 and STANDARD™ H. pylori Ag Control.

Generated automatically from registry data and not verified by a human reviewer.