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AUROLAB

India · Madurai
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia — 5 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
20listed device types
Class I 11Class II 5Class III 3unclassified 1
plus 23 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 1Class II 6
8 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
6active ARTG entries
IIa 1IIb 5
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 States23 registration records, 4 510(k), 0 PMA
Brazil7 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: AUROLAB

Company information

Country
India
City
Madurai

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 510(k) clearances by year

22003 · K024091
12014 · K140039
12022 · K221759

FDA listed device types

showing 8 of 20
Intraocular Lens 1Fluid, Intraocular 1Aid, Surgical, Viscoelastic 1Cannula, Trocar, Ophthalmic 1Ring, Ophthalmic (Flieringa) 1Knife, Ophthalmic 1Trypan Blue 1Chart, Visual Acuity 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221759Cornisol2022-10-05
USK140039POLYCRYL2014-09-15
USK024091SILK SUTURES2003-02-28
BR80420209009GLIDE – Cartucho e injetor descartávelClass II
BR80420209005OCUBLUE PLUS (Solução azul brilhante G 0.05% p/v)Class II
BR80420209006AUROBLUE (Solução Azul de Tripano 0.06% p/v)Class II
CA73192AUROLON, BLACK MONOFILAMENT NYLON, NONABSORBABLE SURGICAL SUTUREClass III

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