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Home›Ireland›Puritan-Bennett Ireland, Ltd.

Puritan-Bennett Ireland, Ltd.

Ireland · Galway
✓ 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
166510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 166 510(k), 7 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
34active device licences
Class II 11Class III 23
42 including historic records
TWTaiwanTFDA
0valid device licences
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 States0 registration records, 166 510(k), 7 PMA, 5 excluded
Brazil3 confirmed, 2 excluded
Canada34 confirmed, 1 excluded
Manufacturer names merged into this page: NELLCOR PURITAN BENNETT INC. (A SUBSIDIARY OF MALLINCKORDT, INC.) · NELLCOR PURITAN BENNETT IRELAND · PURITAN BENNETT CORPORATION, SUBSIDIARY OF MALLINCKRODT · NELLCOR PURITAN BENNETT INC. · NELLCOR PURITAN BENNETT MEXICO, SA DE CV · NELLCOR PURITAN BENNETT INC
Same-named companies — This database also contains companies with near-identical names: Puritan Bennett Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Ireland
City
Galway

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.

FDA 510(k) clearances by year

81991
91992
21993
131994
21995
91996
101997
91998
81999
52000
102002
42003
12004
32005
32006
32007
12008
12009
12010
22013

Registration details (sample)

MarketIdentifierNameClass / date
USK123581NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN2013-05-09
USK123002VITAL SYNC SYSTEM2013-02-27
USK092847840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION2010-03-11
BR10349000226AGULHA DE ACESSO E INSUFLACAO VERSASTEPClass II
BR10349000413Tubo Endotraqueal TaperGuard com Lumen EVACClass II
BR81356112309SONDA DE FOLEY COM NITRATO DE PRATA - DOVER SILVERClass II
CA6997SANDMAN SLEEP DIAGNOSTIC SYSTEM AND SANDMAN NT (SOFTWARE)Class II
CA7959BREATH STAR 340 VENTILATOR SYSTEMClass III
CA12781ASSURANCE 2000 HEAT/RESPIRATION MONITOR (PREVIOUSLY NAMED 2000W)Class III

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