HomeChinaNINGBO LUKE MEDICAL DEVICES CO., LTD.

NINGBO LUKE MEDICAL DEVICES CO., LTD.

China · Yuyao City
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
27listed device types
Class I 22Class II 4Class III 0unclassified 1
plus 27 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
17registered devices
Class II 17
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
0active device licences
5 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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 States27 registration records, 0 510(k), 0 PMA
Brazil17 confirmed, 0 excluded
Manufacturer names merged into this page: NINGBO LUKE MEDICAL DEVICES CO., LTD. · LUKE MEDICAL INC.
Same-named companies — This database also contains companies with near-identical names: LUKE MEDICAL INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Yuyao City

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 listed device types

showing 8 of 27
Cup, Menstrual 1Vibrator For Therapeutic Use, Genital 1Catheter And Tip, Suction 1Enteral Administration Kit (Adult & Pediatric) 1Mask, Oxygen, Non-Rebreathing 1Snare, Surgical 1Airway, Nasopharyngeal 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81878889001Familia de Máscara LaringeaClass II
BR81878889002Familia de Máscara LaringeaClass II
BR81470729005TUBO ENDOTRAQUEAL COM CUFFClass II

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