HomeUSAMEDI/NUCLEAR CORPORATION INC.

MEDI/NUCLEAR CORPORATION INC.

USA · Baldwin Park
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Taiwan — 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
3listed device types
Class I 1Class II 2Class III 0
plus 7 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3active device licences
Class II 3
9 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
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 States7 registration records, 9 510(k), 0 PMA, 35 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada3 confirmed, 3 excluded
Manufacturer names merged into this page: MEDI NUCLEAR CORP., INC. · MEDI/NUCLEAR CORPORATION INC. · MEDI/NUCLEAR CORPORATION, INC.-HEALTHLINE MEDICAL INC.

Company information

Country
USA
City
Baldwin Park

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

11981
11982 · K813379
11986 · K863996
21987 · K865107
11992 · K915075
32008 · K082541

FDA listed device types

System, Rebreathing, Radionuclide 1Nebulizer (Direct Patient Interface) 1Mouthpiece, Breathing 1

Registration details (sample)

MarketIdentifierNameClass / date
USK082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM2008-11-26
USK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-5102008-07-25
USK080657NEB-90 LARGE VOLUME MEDICATION NEBULIZER2008-06-30
CA7110MOUTHPIECE WITH CONNECTORClass II
CA7119AERO/VENT PLUSClass II
CA31339INSTA/VENT, LUNG AEROSOL DELIVERY UNITClass II

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