HomeCosta RicaHologic Surgical Products Costa Rica, S.R.L.

Hologic Surgical Products Costa Rica, S.R.L.

Costa Rica · El Coyol Alajuela
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, South Korea — 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
13listed device types
Class I 6Class II 6Class III 1
plus 33 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
8valid device licences
Class II 8
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
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 States33 registration records, 0 510(k), 0 PMA, 7 excluded
Brazil1 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Hologic Surgical Products Costa Rica, S.R.L. · HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.

Company information

Country
Costa Rica
City
El Coyol Alajuela

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 13
System, Applicator, Radionuclide, Remote-Controlled 1Electrosurgical, Cutting & Coagulation & Accessories 1Instrument, Biopsy 1Hysteroscope (And Accessories) 1Insufflator, Hysteroscopic 1Marker, Radiographic, Implantable 1Probe, Uptake, Nuclear 1Seal, Cervical, Mechanical, Unpowered 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80047300439DISPOSITIVO PARA BIÓPSIA MAMÁRIA ATEC®Class II

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