HomeIndiaPregna International Ltd.

Pregna International Ltd.

India · Mumbai · www.pregna.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN IN-MF-000010389

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Israel — 8 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
1UDI-DI device records
Class IIa 1
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class III 1System or Procedure Pack 1
BRBrazilANVISA
1registered devices
Class I 1
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
2valid device licences
Class II 1Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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.

European Union1 raw hits, 0 excluded, 1 confirmed
United States1 registration records, 0 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: PREGNA INTERNATIONAL LIMITED · PREGNA INTERNATIONAL LTD. · PREGNA INTERNATIONAL LTD

Regulatory identity

EU manufacturer SRN
IN-MF-000010389
EU authorised representative
Medical Technology Promedt Consulting GmbH
UK responsible person
LFH Regulatory Limited

Company information

Country
India
City
Mumbai
Website
www.pregna.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesWomen’s Health, Neonatology & Pediatric CareReproductive health

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.

Business registration

Legal name
PREGNA INTERNATIONAL LIMITED
LEI
98450039A7EA9B158557
Registration status
Active
Legal form
Public Limited Company (Ltd)
Incorporated
1993-08-23
Registered address
13 SURYODAYA ESTATE, 136 TARDEO ROAD, MUMBAI, 400034
Registration authority
Companies Register, no. U25209MH1993PLC073582
Registry record updated
2026-06-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

Sound, Uterine 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08904045301479Class IIa
UK46920Yanae®System or Procedure Pack
UK46920Intrauterine Contraceptive DeviceClass III
BR10208259002HISTERÔMETRO ANDALANClass I

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