HomeUnited Kingdom of Great Britain and Northern IrelandREMEL EUROPE LIMITED

REMEL EUROPE LIMITED

United Kingdom of Great Britain and Northern Ireland · Dartford
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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
68listed device types
Class I 42Class II 26Class III 0
plus 150 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
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
15active device licences
Class II 8Class III 7
30 including historic records
TWTaiwanTFDA
26valid device licences
Class I 22Class II 4
SGSingaporeHSA SMDR
14device registrations
CLASS B 11CLASS C 3
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
AUAustraliaTGA ARTG
4active ARTG entries
IVD Class 1 1IVD Class 2 2IVD Class 3 1
HKHong KongMDACS
11valid listings
IVD B 9IVD C 2
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 States150 registration records, 0 510(k), 0 PMA, 5 excluded
Brazil4 confirmed, 2 excluded
Canada15 confirmed, 2 excluded
Manufacturer names merged into this page: REMEL EUROPE LTD · REMEL EUROPE LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Dartford

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.

Business registration

Company number
04245812
Registration status
Active
Legal form
Private Limited Company
Incorporated
2001-07-04
Principal activity
46900 - Non-specialised wholesale trade
Registered address
3RD FLOOR, 1 ASHLEY ROAD, ALTRINCHAM, WA14 2DT

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 68
Antisera, Cf, Influenza Virus A, B, C 1Antiserum, Fluorescent, Chlamydia Trachomatis 1Antigens, All Types, Escherichia Coli 1Device, Specimen Collection 1Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) 1Antisera, All Types, Escherichia Coli 1Enzyme Linked Immunoabsorbent Assay, Rotavirus 1Antisera, All Types, Streptococcus Pneumoniae 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80254180250PROSPECT ENTAMOEBA HISTOLYTICA KITClass II
BR80254180246PROSPECT ROTAVIRUSClass II
BR80254180293PROSPECT GIARDIA KITClass II
CA4746THROMBO-WELLCOTEST SAMPLE COLLECTION TUBESClass II
CA11105INNO LIPA DRB 1*04Class III
CA11106INNO LIPA DQB AMPLIFICATION AND PRIMERClass III

Similar companies

2BScientific Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 0
AbBaltis Ltd
United Kingdom of Great Britain and Northern Ireland · markets 0
Advanced Molecular Diagnostics Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 3
Air Moving Products Ltd Trading as Steady Moto
United Kingdom of Great Britain and Northern Ireland · markets 0
Albert Waeschle Ltd
United Kingdom of Great Britain and Northern Ireland · markets 3
Alerta Medical Ltd.
United Kingdom of Great Britain and Northern Ireland · markets 5
Is this your company? Claim the page, add information or report a data error.Claim / report an error →