HomeUSALANSINOH LABORATORIES, INC.

LANSINOH LABORATORIES, INC.

USA · Alexandria
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 5 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 2Class II 1Class III 0
plus 7 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 7Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
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
1registrations
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, 4 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: Lansinoh Laboratories Saglik Gerecleri Tasarim SanTicLtdSti · LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD. STI · LANSINOH LABORATORIES, INC. · LANSINOH LABORATORIES INC · Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic. Ltd. · Lansinoh Laboratories

Company information

Country
USA
City
Alexandria

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

12012 · K122474
12019 · K182749
12022 · K222726
12023 · K230469

FDA listed device types

Pump, Breast, Powered 1Pump, Breast, Non-Powered 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230469Compact Wearable Pump2023-06-30
USK222726Smartpump 3.0 Double Electric Breast Pump2022-12-23
USK182749Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump2019-06-12
BR81319579006BOMBA TIRA-LEITE ELÉTRICA LANSINOHClass II
BR81319579001BOMBA TIRA LEITE MANUAL LANSINOHClass I
BR81319579002Lansinoh LatchAssistClass I
SAME0000004715SFDAA00002Lasinoh Compact Single Electric Breast pump
SAME0000004714SFDAA00003Lasinoh 2 in 1 Electric Breast Pump
CA105510LANSINOH COMPACT SINGLE ELECTRIC BREAST PUMPClass II
CA91656AFFINITY DOUBLE ELECTRIC BREAST PUMPClass II
CA73564LANSINOH DOUBLE ELECTRIC BREAST PUMPClass II

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