HomeJapanNittobo Medical Co., Ltd.

Nittobo Medical Co., Ltd.

Japan · Tokyo · nittobo-nmd.co.jp/english/index.html
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 3 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
30listed device types
Class I 9Class II 21Class III 0
plus 44 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
17valid device licences
Class I 7Class II 10
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
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 States44 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER

Company information

Country
Japan
City
Tokyo
Website
nittobo-nmd.co.jp/english/index.html
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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 30
Igm, Antigen, Antiserum, Control 1Calibrator, Secondary 1Test, Cystatin C 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1Iga, Antigen, Antiserum, Control 1Haptoglobin, Antigen, Antiserum, Control 1Test, Fibrinogen 1

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