HomeUnited Kingdom of Great Britain and Northern IrelandPRO - LAB Diagnostics Ltd.

PRO - LAB Diagnostics Ltd.

United Kingdom of Great Britain and Northern Ireland · Bromborough Merseyside · www.pro-lab.com
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Canada, Taiwan, Singapore, Australia, 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
0UDI-DI device records
USUnited StatesFDA openFDA
13listed device types
Class I 10Class II 3Class III 0
plus 13 registration records and 33 510(k)
UKUnited KingdomMHRA PARD
68registered device records
Class I 1IVD A 26IVD general 41
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
10active device licences
Class II 9Class III 1
14 including historic records
TWTaiwanTFDA
6valid device licences
Class I 6
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 2 2
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.

European Union190,156 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States13 registration records, 33 510(k), 0 PMA, 83 excluded
United Kingdom68 confirmed, 535 excluded
Brazil0 confirmed, 23 excluded
Saudi Arabia0 confirmed, 6 excluded
Canada10 confirmed, 8 excluded
Manufacturer names merged into this page: pro-lab incorporated · PRO-LAB DIAGNOSTICS

Regulatory identity

UK responsible person
Microlink Technology Ltd T/A Pro-Lab Diagnostics

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Bromborough Merseyside
Website
www.pro-lab.com

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

Legal name
PRO-LAB DIAGNOSTICS LIMITED
Company number
11054945
Registration status
Active
Legal form
Private Limited Company
Incorporated
2017-11-08
Principal activity
99999 - Dormant Company
Registered address
STANHOPE HOUSE, BROMBOROUGH, CH62 2DN

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

FDA 510(k) clearances by year

61984
91985
31986
21987
21988
11989
11991
61992
11993
11994
11995

FDA listed device types

showing 8 of 13
Antisera, All Groups, Streptococcus Spp. 1Antigens, All Types, Escherichia Coli 1Culture Media, Single Biochemical Test 1Supplement, Culture Media 1Plasma, Coagulase, Human, Horse And Rabbit 1Antisera, All Types, Escherichia Coli 1Antisera, Fluorescent, All Types, Staphylococcus Spp. 1Sampler, Amniotic Fluid (Amniocentesis Tray) 1

Registration details (sample)

MarketIdentifierNameClass / date
UK49856Proflow AdenovirusIVD general
UK51707Proflow Streptococcus AIVD general
UK43587Leishman's StainIVD A
USK934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)1995-01-27
USK944421E.COLI 0157 LATEX TEST1994-12-15
USK914419AMNIOTEST(TM)1993-09-01
CA65187ROTA/ADENO COMBI-STICKClass II
CA71522CT-US-IRMA (CALCITONIN)Class II
CA71885HOST - IRMA (HUMAN INTACT OSTEOCALCIN) KITClass II

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 →