Home›USA›REMEL, INC.

REMEL, INC.

USA · Lenexa

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel — 7 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

74listed device types

Class I 53Class II 21Class III 0

plus 185 registration records and 154 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 16Class II 3

20 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

11active device licences

Class II 10Class III 1

32 including historic records

TWTaiwanTFDA

16valid device licences

Class I 15Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 4IVD Class 2 5IVD Class 3 3

HKHong KongMDACS

13valid listings

IVD B 12IVD C 1

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 States185 registration records, 154 510(k), 0 PMA, 3 excluded

Brazil19 confirmed, 1 excluded

Canada11 confirmed, 2 excluded

Manufacturer names merged into this page: REMEL, INC. · REMEL INC. · REMEL INC

FDA 510(k) clearances by year

31985

31986

101987

51988

31989

21990

171991

161992

91993

71994

31996

91997

11998

12001

42003

22004

12007

12010

12013

12017

FDA listed device types

showing 8 of 74

Stains, Microbiologic 1Device, Specimen Collection 1Iodine, Grams 1Antisera, All Types, Escherichia Coli 1Nephelometer, For Clinical Use 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Culture Media, Enriched 1Culture Media, Non-Selective And Non-Differential 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162620	Remel Spectra ESBL	2017-05-01
US	K131804	REMEL XPECT FLU A&B	2013-07-12
US	K092407	REMEL SPECTRA MRSA	2010-10-08
BR	80254180239	XPECT FLU A/B	Class II
BR	80254180244	RAPID CB PLUS SYSTEM	Class I
BR	80254180247	RAPID ONE SYSTEM	Class I
CA	78699	MICROTEST M5	Class II
CA	599	PATHODX STREP A PHYSICIAN'S KIT	Class III
CA	7008	LMD TETANUS TOXOID MICROWELL ELISA	Class II

REMEL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies