Boditech Med, Inc.
South Korea Last updated 22 Oct 2026
- Devices
- 262
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
hemochroma PLUS Calibrator Ref CFPO-35
AFIAS CK-MB Neo Ref SMFP-128
AFIAS Tn-I Plus Ref SMFP-35
C-tip (30 μL) Ref CFPO-199
AFIAS PCT Plus Ref SMFP-85
AFIAS Dengue NS1 Ag Ref SMFP-44
AFIAS D-Dimer Neo Ref SMFP-129
5 μL Capillary tube Ref CFPO-32
i-Chamber Ref FPRR009
AFIAS Rituximab Ref SMFP-110
AFIAS Dengue IgG/IgM Ref SMFP-41
QDx Instacheck™ System check cartridge Ref FPCC156
AFIAS Adalimumab Ref SMFP-89
Boditech CRP Calibrator Ref CFPO-112
AFIAS Testosterone Ref SMFP-29
ALCIS Folate Control Ref ACCO-09
Afias Igra-Tb Ref SMFP-99
Alchemis Ref FPRR048
AFIAS Flu A+B Ref SMFP-68
Boditech Cyfra21-1 Calibrator Ref CFPO-364
Alcis Tsh Ref ACFP-01-50
AFIAS Vitamin D Neo Ref SMFP-108
C-tip (10 μL) Ref CFPO-91
ALCIS TSH Calibrator Ref ACCA-01
Afias Prl Ref SMFP-8
AFIAS MxA/CRP Ref SMFP-102
Alcis T3 Ref ACFP-05-50
10 μL Capillary tube Ref CFPO-295
ALCIS AMH Control Ref ACCO-18
AFIAS Microalbumin Ref SMFP-30
Boditech Calprotectin Calibrator Ref CFPO-380
AFIAS Ustekinumab Ref SMFP-114
AFIAS Carba5 NDM Ref SMFP-163
ichroma™ Free PSA Ref CFPC-178
ez-Tracker System check cartridge Ref ET001-SC
AFIAS Rota/Adeno Ref SMFP-43
Afias Amh Ref SMFP-62
ALCIS Testosterone Control Ref ACCO-12
ALCIS β-hCG Control Ref ACCO-16
Afias Bar/Bzo/Tca Ref SMFP-154
AFIAS COVID-19/Flu A+B/RSV Ag Combo Ref SMFP-113
Alchemis LiverLipid Kit Ref AMFP-03
Afias Igf-1 Ref SMFP-167
AFIAS Zika IgG/IgM Ref SMFP-40
ALCIS Estradiol Ref ACFP-11-50
Boditech Insulin Calibrator Ref CFPO-423
Afias Afp Ref SMFP-27
ALCIS FSH Control Ref ACCO-14
ALCIS Vitamin D Ref ACFP-10-50
Afias Saa Ref SMFP-138
Showing 101-150 of 262
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- V76 053112 0038 Issued
Technical documentation EU IVDR
- Issued
- 21 Sep 2026
- Expires
- 20 Sep 2031
Related companies
Notified bodies
FDA establishments
- Boditech Med Inc. Chuncheon Gangwon · KR FEI 3009491259
What Boditech Med, Inc. makes
Boditech Med, Inc. manufactures in vitro diagnostics (IVDs) for laboratory and point-of-care use, including reagents for thyroid stimulating hormone (TSH), faecal occult blood, and C-reactive protein (CRP), as well as nucleic acid extraction kits and immunoassay analysers. Their products include semi-automated analysers for CRP and faecal occult blood testing, rapid antigen tests for SARS-CoV-2, and specimen processing instruments. The company also supplies TSH controls and calibrators, as well as home-based COVID-19 antigen self-tests.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and the Unique Device Identifier (UDI) system, spanning Class I and Class II classifications. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.
Frequently asked questions
How many devices does Boditech Med, Inc. have in the registry?
The registry currently lists 262 devices for Boditech Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
What EUDAMED certificates are recorded for Boditech Med, Inc.?
EUDAMED lists 1 certificate for Boditech Med, Inc. (technical documentation) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2026-09-21.
Which FDA establishments are linked to Boditech Med, Inc.?
1 FDA establishment is linked to Boditech Med, Inc. in the registry; they are listed on the company page.
Information
- Address
- 43, Geodudanji 1-gil, Chuncheon-si, South Korea
- Website
- www.boditech.co.kr/en
- [email protected]
- Phone
- +82 33 243 1400
- PRRC contact
- Sung Chul BAHN
- EUDAMED SRN
- KR-MF-000011028
- DUNS number
- 689062203