HomeOPTOLANE Technologies Inc.

OPTOLANE Technologies Inc.

www.optolane.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN KR-MF-000026042

This company has registrations in European Union, United States, Brazil, Israel — 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
9UDI-DI device records
IVD A 8IVD general 1
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
3registered devices
Class II 3
4 including historic records
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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union9 raw hits, 0 excluded, 9 confirmed
United States1 registration records, 0 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: OPTOLANE TECHNOLOGIES, INC. · OPTOLANE TECHNOLOGIES INC.

Regulatory identity

EU manufacturer SRN
KR-MF-000026042
EU authorised representative
CMC Medical Devices & Drugs SL
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Employees
10–50
Annual revenue
RMB 5–10M
Company type
Manufacturer
Website
www.optolane.com

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

Real Time Nucleic Acid Amplification System 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08809740940087Dr. PCR™ BCR-ABL1 Major IS Detection KitIVD general
EU08809740940124LOAA-M Powerbox SystemIVD A
EU08809740940179Dr. PCR 20K Cartridge -PFIVD A
EU08809740940162D_PCR Chip CaseIVD A
BR80102513599Família LOAA-M Powerbox SystemClass II
BR80102513081Analisador LOAA (On-Point)Class II
BR80102513143Sistema LOAA-MClass II

Similar companies

Tecnomed Medikal Sistemler Sanayi
· markets 0
Sonictec
· markets 0
CURE BIOTECH Co.,Ltd.
· markets 0
WUHAN PAKCARE BIO-TECHNOLOGY CO.,LTD
· markets 7
Innosonian Inc
· markets 0
Mun Global Sdn Bhd
· markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →