HomeBelgiumAptec Diagnostics N.V.

Aptec Diagnostics N.V.

Belgium · Sint-Niklaas · www.aptec.be
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in Brazil, Russia — 2 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
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
22registered devices
Class II 22
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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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.

Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: APTEC DIAGNOSTICS · APTEC DIAGNOSTICS NV

Company information

Country
Belgium
City
Sint-Niklaas
Website
www.aptec.be
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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
APTEC Diagnostics
LEI
967600HQ0ZF4QC6ETY68
Registration status
Active
Registered address
Industriepark West 42C, Sint Niklaas, 9100
Registration authority
Crossroad Bank of Enterprises, no. 0451876874
Registry record updated
2018-12-27

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

Registration details (sample)

MarketIdentifierNameClass / date
BR10350840067CERULOPAMIN AUT KIT (CERULOPLASMINA AUT KIT)Class II
BR10350840068ALFA-1-ANTTRIPSIN AUT KIT(ALFA-1-ANTITRIPINA AUTKIT)Class II
BR10350840070HAPTOGLOBIN AUT KIT(HAPTOGLOBINA AUT KIT)Class II

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