HomeFranceNG BIOTECH SAS

NG BIOTECH SAS

France · Guipry Bretagne
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 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
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 4Class II 3
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
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 3 1
HKHong KongMDACS
2valid listings
IVD C 2
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States2 registration records, 2 510(k), 0 PMA
Brazil7 confirmed, 1 excluded
Manufacturer names merged into this page: NG BIOTECH · NG BIOTECH SAS

Company information

Country
France
City
Guipry Bretagne

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 510(k) clearances by year

12019 · K191889
12025 · K243499

FDA listed device types

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates 1

Registration details (sample)

MarketIdentifierNameClass / date
USK243499NG-Test® CTX-M MULTI2025-06-04
USK191889NG-Test CARBA 52019-10-02
BR80113770045Família Teste de Gravidez de SangueClass II
BR10097010172NG-TEST CARBA 5Class II
BR10097010175NG-TEST CTX-M MULTIClass I

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