HomeCanadaJac-Cell Medic Corporation

Jac-Cell Medic Corporation

Canada · Mont-Royal
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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 1 registration records and 2 510(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
24active device licences
Class II 24
63 including historic records
TWTaiwanTFDA
pendingnot queried
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 States1 registration records, 2 510(k), 0 PMA, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada24 confirmed, 0 excluded
Manufacturer names merged into this page: JAC-CELL MEDIC

Company information

Country
Canada
City
Mont-Royal

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

12002 · K020334
12017 · K170105

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170105Jac-Cell Medic testers2017-02-28
USK020334INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC2002-10-03
CA68687DISPOSABLE IRRIGATION/ASPIRATION TUBING SETClass II
CA76111SURGICAL PENCILSClass II
CA77184REUSABLE LAPAROSCOPIC SCISSORS (POWERED)Class II

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