HomeKorea, RepublicChungdo Pharm Co., Ltd.

Chungdo Pharm Co., Ltd.

Korea, Republic · Chuncheon-Si Gangwon-do · www.ichungdo.com
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 4 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
0UDI-DI device records
USUnited StatesFDA openFDA
13listed device types
Class I 10Class II 3Class III 0
plus 12 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
4valid device licences
Class I 3Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 2 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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.

United States12 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: CHUNGDO PHARM. CO., LTD. · CHUNGDO PHARM CO., LTD.

Company information

Country
Korea, Republic
City
Chuncheon-Si Gangwon-do
Website
www.ichungdo.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassaysHome & self-testing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 13
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Dye-Indicator, Ph (Urinary, Non-Quantitative) 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Automated Urinalysis System 1Test, Urine Leukocyte 1Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Refractometer For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80464810795Self-Stik NO (Nitric Oxide) Saliva Test StripClass II
BR80464810796Self-Stik FR Test StripClass II

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