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Home›USA›PEMCO, INC.

PEMCO, INC.

USA · Cleveland
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 4 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 0 510(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
3active device licences
Class II 3
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States4 registration records, 0 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: PEMCO, INC. · PEMCO INC.

Company information

Country
USA
City
Cleveland

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

Stabilizer, Heart 1Instruments, Surgical, Cardiovascular 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Sucker, Cardiotomy Return, Cardiopulmonary Bypass 1

Registration details (sample)

MarketIdentifierNameClass / date
CA86655INTRACARDIAC SUCKERClass II
CA86656PERFUSION CANNULAClass II
CA86844INTRACARDIAC SUCKER TIPClass II

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