HomeIndiaSigma Surgical Private Limited

Sigma Surgical Private Limited

India · Ahmedabad · www.sorathortho.co.in
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 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
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class I 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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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.

European Union1,104 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States2 registration records, 0 510(k), 0 PMA, 27 excluded
United Kingdom0 confirmed, 5 excluded
Brazil1 confirmed, 2 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 5 excluded
Manufacturer names merged into this page: SIGMA SURGICAL PRIVATE LIMITED

Company information

Country
India
City
Ahmedabad
Website
www.sorathortho.co.in
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationTrauma systems

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

LEI
984500DED91AE5F48905
Registration status
Active
Legal form
Private Limited Company (Pvt Ltd)
Incorporated
1998-01-05
Registered address
Survey No. 1636/1, Ahmedabad, 382433
Registration authority
Companies Register, no. U33110GJ1998PTC033520
Registry record updated
2026-06-15

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

Orthopedic Manual Surgical Instrument 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80695710047Kit de instrumentos de reconstrução LCA-LCPClass I

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