HomeSpainOperon S.A.

Operon S.A.

Spain · Cuarte de Huerva (Zaragoza) · www.operondx.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN ES-MF-000004790

This company has registrations in European Union, United States, United Kingdom, Taiwan, Singapore — 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
92UDI-DI device records
IVD B 57IVD C 2IVD general 28ivd-annex-ii-list-b 5
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
30registered device records
IVD B 13IVD general 17
BRBrazilANVISA
0registered devices
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
11valid device licences
Class I 11
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
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.

European Union92 raw hits, 0 excluded, 92 confirmed
United States1 registration records, 0 510(k), 0 PMA
United Kingdom30 confirmed, 0 excluded
Manufacturer names merged into this page: OPERON, S.A.

Regulatory identity

EU manufacturer SRN
ES-MF-000004790
UK responsible person
Launch Diagnostics Limited

Company information

Country
Spain
City
Cuarte de Huerva (Zaragoza)
Website
www.operondx.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassaysMolecular diagnostics & genomicsPCR & qPCRMicrobiology & infectious disease diagnosticsPoint-of-care & near-patient testing

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
OPERON, S.A
LEI
9598001LQCBW3FFK6Y24
Registration status
Active
Legal form
Sociedad Anonima (S.A.)
Incorporated
1973-10-20
Registered address
CAMINO DEL PLANO, S/N, Cuarte de Huerva, 50410
Registration authority
Commercial Registry, no. 1000106483261
Registry record updated
2026-08-19

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

Helicobacter Pylori 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08429577003122Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)IVD B
EU08429577003139Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)IVD B
EU08429577008233VIRAPID® ROTA/ADENO AgIVD B
EU08429577008264SIMPLE ROTA-ADENO / STICK ROTA-ADENOIVD B
UK49856Simple RespirAdenoIVD B
UK51707Simple Strep AIVD B
UK53626Dry Positive Control CalprotectinaIVD general

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