HomeUnited Kingdom of Great Britain and Northern IrelandPenlon Limited

Penlon Limited

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

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 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
6listed device types
Class I 2Class II 4Class III 0
plus 8 registration records and 22 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 2Class III 4
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 States8 registration records, 22 510(k), 0 PMA
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: PENLON LTD. · PENLON LIMITED

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Abingdon

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
03228364
Registration status
Active
Legal form
Private Limited Company
Incorporated
1996-07-23
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
1-5 BARTON LANE, ABINGDON, OX14 3NB

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

21980
21981
11983
21985
11989
11990
11994
21995
21996
32001
12004
12005
32006

FDA listed device types

Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Gas-Machine, Anesthesia 1Ventilator, Continuous, Facility Use 1Vaporizer, Anesthesia, Non-Heated 1Tube, Thorpe, Uncompensated 1Laryngoscope, Rigid 1

Registration details (sample)

MarketIdentifierNameClass / date
USK061102PRIMA ANAESTHESIA MACHINE2006-07-28
USK060331SIGMA ALPHA VAPORIZER2006-05-10
USK053564KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 534542006-03-03
CA66044PENLON CRYSTAL LARYNGOSCOPE BLADESClass II
CA20350SIGMA ELITE VAPORIZERClass III
CA23081PRIMA ANESTHESIA MACHINEClass III

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