HomeUnited Kingdom of Great Britain and Northern IrelandBBI Solutions OEM Limited

BBI Solutions OEM Limited

United Kingdom of Great Britain and Northern Ireland · Crumlin · www.bbisolutions.com
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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
5listed device types
Class I 4Class II 1Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
3active device licences
Class II 3
6 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 Union388 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States5 registration records, 0 510(k), 0 PMA
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 4 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: BBI SOLUTIONS OEM LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Crumlin
Website
www.bbisolutions.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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
08368483
Registration status
Active
Legal form
Private Limited Company
Incorporated
2013-01-21
Principal activity
20130 - Manufacture of other inorganic basic chemicals / 20590 - Manufacture of other chemical products n.e.c.
Registered address
C/O BERRY SMITH LLP HAYWOOD HOUSE, CARDIFF, CF10 3GA

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

System, Detection, Bacterial, For Platelet Transfusion Products 1Antigens, All Types, Escherichia Coli 1Campylobacter Spp. 1Reagents, Clostridium Difficile Toxin 1Devices Detecting Influenza A, B, And C Virus Antigens 1

Registration details (sample)

MarketIdentifierNameClass / date
CA20157AUTO DIMERTESTClass II
CA63608DIMERTEST LATEXClass II
CA63653SIMPLIFY D-DIMERClass II

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