HomeDominican RepublicMICROTEK DOMINICANA, S.A.S.

MICROTEK DOMINICANA, S.A.S.

Dominican Republic · La Romana La Romana
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 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
37listed device types
Class I 13Class II 23Class III 0unclassified 1
plus 52 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 I 9
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 States52 registration records, 0 510(k), 0 PMA, 8 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: MICROTEK DOMINICANA, S.A.S. · Microtek Dominicana, S.A.S.

Company information

Country
Dominican Republic
City
La Romana La Romana

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 37
Dress, Surgical 1Accessory, Surgical Apparel 1Urinal 1Accessories, Arthroscopic 1Bag, Intestine 1Airway, Oropharyngeal, Anesthesiology 1Bedding, Disposable, Medical 1Shield, Protective, Personnel 1

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