HomeSwedenJOLIFE AB

JOLIFE AB

Sweden · Lund
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 5 510(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
1active device licences
Class II 1
3 including historic records
TWTaiwanTFDA
1valid device licences
Class III 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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, 5 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: JOLIFE AB

Company information

Country
Sweden
City
Lund

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

22006 · K062401
12009 · K090422
12016 · K161768
12018 · K173553

FDA listed device types

Compressor, Cardiac, External 1

Registration details (sample)

MarketIdentifierNameClass / date
USK173553LUCAS 3 Chest Compression System2018-02-08
USK161768LUCAS 3 Chest Compression System2016-11-09
USK090422LUCAS 22009-06-17
CA72076LUCAS CHEST COMPRESSION SYSTEMClass II

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