HomeUnited Kingdom of Great Britain and Northern IrelandHelena Laboratories Uk, Ltd.

Helena Laboratories Uk, Ltd.

United Kingdom of Great Britain and Northern Ireland · Gateshead Newcastle Upon Tyne
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
pendingnot queried
USUnited StatesFDA openFDA
50listed device types
Class I 19Class II 31Class III 0
plus 139 registration records and 283 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
51registered devices
Class I 9Class II 42
57 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
58active device licences
Class II 53Class III 5
85 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
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.

United States139 registration records, 283 510(k), 0 PMA
Brazil51 confirmed, 2 excluded
Canada58 confirmed, 0 excluded
Manufacturer names merged into this page: HELENA LABORATORIES, CORP. · Helena Laboratories UK Ltd · HELENA LABORATORIES, CORP · HELENA LABORATORIES (UK) LTD. TRADING AS HELENA BIOSCIENCES EUROPE · HELENA LABORATORIES · HELENA LABORATORIES, INC.
Same-named companies — This database also contains companies with near-identical names: HELENA LABORATORIES, CORP., HELENA LABORATORIES (UK) LTD. TRADING AS HELENA BIOSCIENCES EUROPE. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Gateshead Newcastle Upon Tyne

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
HELENA LABORATORIES (U.K.) LIMITED
Company number
01796207
Registration status
Active
Legal form
Private Limited Company
Incorporated
1984-03-01
Principal activity
32990 - Other manufacturing n.e.c.
Registered address
UNIT B, M361, QUEENSWAY SOUTH, GATESHEAD, NE11 0SD

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

191991
191992
101993
101994
81995
81996
31997
61998
31999
22000
32001
72002
22003
12005
22006
12007
12010
12012
12013
22022

FDA listed device types

showing 8 of 50
Igm, Antigen, Antiserum, Control 1Test, Thrombin Time 1System, Analysis, Electrophoretic Hemoglobin 1Assay, Heparin 1Instrument, Coagulation, Automated 1Plasma, Control, Normal 1Igd, Antigen, Antiserum, Control 1Electrophoretic, Lactate Dehydrogenase Isoenzymes 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213396SPIFE A1AT kit2022-10-13
USK192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control2022-04-19
USK131479V8 SP NORMAL CONTROL, ABNORMAL CONTROL2013-10-07
BR10230730101Kit para Eletroforese SPIFE CKClass II
BR10230730097Kit de Eletroforese para LipoproteínaClass II
BR10230730098Proteína S Livre MonoclonalClass II
CA6185TITAN GEL LD ISOENZYME KITClass II
CA6188TITAN GEL ISO DOT LD ISOENZYME KITClass II
CA6871L/S RATIOClass II

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