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Home›USA›RESPIRATORY DELIVERY SYSTEMS, INC.

RESPIRATORY DELIVERY SYSTEMS, INC.

USA · Chelmsford
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
5active device licences
Class II 5
6 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 States1 registration records, 4 510(k), 0 PMA, 12 excluded
Brazil4 confirmed, 1 excluded
Saudi Arabia3 confirmed, 1 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: RESPIRATORY DELIVERY SYSTEMS, INC. · RESPIRATORY DELIVERY SYSTEM, INC. · RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. · Respironics Respiratory Drug Delivery UK Ltd · Respironics Respiratory Drug Delivery (UK) Ltd
Same-named companies — This database also contains companies with near-identical names: RESPIRATORY DELIVERY SYSTEM, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Chelmsford

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

11990 · K903413
11992 · K915211
12011 · K102454
12017 · K170853

FDA listed device types

Mouthpiece, Breathing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170853InnoSpire Go2017-11-02
USK102454I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM2011-10-25
USK915211MICROCHAMBER1992-05-20
BR10216710248PERSONAL BEST MEDIDOR DE FLUXO.Class I
BR10216719013PROCHAMBER.Class I
BR10216710247THRESHOLD - DISPOSITIVO PARA TREINAMENTO MUSCULAR RESPIRATÓRIO E PARA Class I
SAME0000000594SFDAA00001OptiChamber Diamond—
SAME0000000933SFDAA00002OptiChamber Diamond anti-static valved holding chamber—
CA8554MICROCHAMBERClass II
CA71100PRODOSE NEBULIZER SYSTEMClass II
CA70599PRODOSE NEBULIZER SYSTEMClass II

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