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GERMAINE LABORATORIES, INC.

USA · San Antonio

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Israel — 5 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

79listed device types

Class I 27Class II 49Class III 0unclassified 3

plus 69 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States69 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: GERMAINE LABORATORIES, INC.

FDA 510(k) clearances by year

11997 · K973825

41998 · K981165

11999 · K991369

12002 · K013857

12005 · K051727

FDA listed device types

showing 8 of 79

Kit, Test, Pregnancy, Hcg, Over The Counter 1System, Hemoglobin, Automated 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Test, Propoxyphene, Over The Counter 1Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 1Devices Detecting Influenza A, B, And C Virus Antigens 1System, Test, Rheumatoid Factor 1

Market	Identifier	Name	Class / date
US	K051727	AIMSTICK URINE REAGENT STRIPS	2005-10-26
US	K013857	AIMSTEP PREGNANCY	2002-01-22
US	K991369	ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY	1999-05-10

GERMAINE LABORATORIES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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