HomeUnited Kingdom of Great Britain and Northern IrelandALBA BIOSCIENCE LIMITED

ALBA BIOSCIENCE LIMITED

United Kingdom of Great Britain and Northern Ireland · Penicuik
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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
6listed device types
Class I 1Class II 4Class III 0unclassified 1
plus 14 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
7active device licences
Class II 6Class III 1
38 including historic records
TWTaiwanTFDA
15valid device licences
Class II 15
SGSingaporeHSA SMDR
8device registrations
CLASS C 5CLASS D 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
IVD Class 1 1IVD Class 2 4IVD Class 3 3IVD Class 4 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
2active registrations
Class 3 2
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 States14 registration records, 0 510(k), 0 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Canada7 confirmed, 0 excluded
Manufacturer names merged into this page: ALBA BIOSCIENCE LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Penicuik

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
SC310584
Registration status
Active
Legal form
Private Limited Company
Incorporated
2006-10-18
Principal activity
21100 - Manufacture of basic pharmaceutical products
Registered address
5 JAMES HAMILTON WAY, PENICUIK, EH26 0BF

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

Media, Potentiating For In Vitro Diagnostic Use 1Solution, Stabilized Enzyme 1Lectins And Protectins 1Kit, Quality Control For Blood Banking Reagents 1Kit, Cell Screening, Fetal 1Supplies, Blood-Bank 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81246986922Ortho Elution KitClass I
CA73173ALBACHECK - BGS PROFICIENCY TESTClass II
CA73610ALBACHECK - BGS ENZYME CONTROL (GLYCINE SOJA)Class II
CA76469O ADULT I(LOWERCASE) RED CELLSClass III

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