HomeDominican RepublicFENWAL INTERNATIONAL, INC.

FENWAL INTERNATIONAL, INC.

Dominican Republic · Haina San Cristobal
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, South Korea — 3 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
21listed device types
Class I 6Class II 13Class III 0unclassified 2
plus 67 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
0active device licences
TWTaiwanTFDA
9valid device licences
Class II 9
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States67 registration records, 0 510(k), 0 PMA, 4 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: FENWAL INTERNATIONAL, INC.

Company information

Country
Dominican Republic
City
Haina San Cristobal

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

showing 8 of 21
Catheter, Continuous Flush 1Separator, Automated, Blood Cell, Diagnostic 1Set, Blood Transfusion 1Bone Marrow Collection/Transfusion Kit 1Pump, Infusion 1Apparatus, Autotransfusion 1Set, Transfer (Blood/Plasma) 1Set, Administration, Intravascular 1

Similar companies

National Free Zones Council of the Dominican R
Dominican Republic · markets 1
AccuMed Corp.
Dominican Republic · markets 1
AJR International S.R.L.
Dominican Republic · markets 1
ARRIOL INTERNATIONAL CORP.
Dominican Republic · markets 2
Baxter Healthcare, S.A.
Dominican Republic · markets 11
Biotek-Caribbean
Dominican Republic · markets 1
Is this your company? Claim the page, add information or report a data error.Claim / report an error →