HomeChinaLifetech Scientific (Shenzhen) Co., Ltd.

Lifetech Scientific (Shenzhen) Co., Ltd.

China · Shenzhen
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Hong Kong, Israel, Russia — 8 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
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
22 including historic records
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
15valid device licences
Class II 6Class III 9
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
5GMP quality-system certificates
Business type not stated 1Import 4
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
14valid listings
Class II 1Class IV 13
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
14active registrations
Class 2b 1Class 3 13
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 States3 registration records, 3 510(k), 0 PMA, 3 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: LIFETECH SCIENTIFIC (SHENZHEN) CO,.LTD · LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD.

Company information

Country
China
City
Shenzhen

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

12010 · K102484
12011 · K100184
12013 · K123842

FDA listed device types

Device, Percutaneous Retrieval 1Catheter, Percutaneous 1Dilator, Vessel, For Percutaneous Catheterization 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123842LAWMAX DILATOR2013-06-24
USK100184FUSTAR STEERABLE INTRODUCERS2011-02-14
USK102484SEQURE SNARE SYSTEM2010-11-09

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