Boditech Med Inc.

Korea, Republic · Chuncheon-si Gangwon-do · www.boditech.co.kr

✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000011028

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

96UDI-DI device records

IVD A 39IVD B 15IVD C 42

USUnited StatesFDA openFDA

15listed device types

Class I 10Class II 5Class III 0

plus 13 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

162registered device records

IVD A 1IVD C 7IVD general 154

BRBrazilANVISA

70registered devices

Class I 2Class II 68

116 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class II 1

34 including historic records

TWTaiwanTFDA

44valid device licences

Class I 13Class II 31

SGSingaporeHSA SMDR

6device registrations

CLASS B 4CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

18active registrations

Class 2a 12Class 2b 3Class 3 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union96 raw hits, 0 excluded, 96 confirmed

United States13 registration records, 2 510(k), 0 PMA, 1 excluded

United Kingdom162 confirmed, 0 excluded

Brazil70 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: BODITECH MED INC. · BODITECH MED INCORPORATED · BODITECH MED INC

Regulatory identity

EU manufacturer SRN: KR-MF-000011028
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

Business registration

KRX ticker code: 206640
Registration status: Active
Incorporated: 2014-12-29

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12014 · K132167

12017 · K170232

FDA listed device types

showing 8 of 15

Radioimmunoassay, Follicle-Stimulating Hormone 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Immunoreactive Insulin 1Radioimmunoassay, Estradiol 1Fluorometer, For Clinical Use 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Radioimmunoassay, C-Peptides Of Proinsulin 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08806133010303	ichroma™ III	IVD A
EU	08806133050583	Boditech Estradiol Control	IVD B
EU	08806133048498	Boditech PSA Control	IVD C
EU	08806133050590	Boditech Estradiol Calibrator	IVD B
UK	60380	AFIAS Total IgE	IVD general
UK	58411	Boditech AMH Control	IVD general
UK	58410	AFIAS AMH	IVD general
US	K170232	AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer	2017-10-13
US	K132167	I-CHROMA IFOB WITH I-CHROMA READER	2014-05-02
BR	10350840447	Família AFIAS Testosterone	Class II
BR	10350840473	Família ichroma	Class II
BR	10350840297	iCHROMA II	Class II
CA	100362	ICHROMA M INFLUENZA A+B	Class II

Boditech Med Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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