HomeGermanyDiaSys Diagnostic Systems GmbH

DiaSys Diagnostic Systems GmbH

Germany · Holzheim · www.diasys-diagnostics.com
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, South Korea, Israel, Russia — 7 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
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
50registered device records
IVD A 1IVD general 49
BRBrazilANVISA
71registered devices
Class I 1Class II 70
72 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
61valid device licences
Class I 25Class II 36
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
20active registrations
Class 1 5Class 2a 14Class 2b 1
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 States5 registration records, 2 510(k), 0 PMA
United Kingdom50 confirmed, 0 excluded
Brazil71 confirmed, 0 excluded
Manufacturer names merged into this page: DIASYS DIAGNOSTIC SYSTEMS GMBH · DIASYS DIAGNOSTIC SYSTEMS GMBH & CO · DIASYS DIAGNOSTIC SYSTEMS GMBH & CO.

Regulatory identity

UK responsible person
Eurobio Scientific UK Ltd

Company information

Country
Germany
City
Holzheim
Website
www.diasys-diagnostics.com
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

LEI
529900UG9GZ698FD0081
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
2002-11-20
Registration authority
Commercial Register, no. HRB 7106
Registry record updated
2025-12-09

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

FDA 510(k) clearances by year

12008 · K080485
12025 · K242294

FDA listed device types

Calibrator, Multi-Analyte Mixture 1Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1

Registration details (sample)

MarketIdentifierNameClass / date
UK45803TruCal Albumin U/CSFIVD general
UK37721TruLab Albumin U/CSF Level 1IVD general
UK53332ß-Hydroxybutyrate Standard FS*IVD general
USK242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls2025-05-09
USK080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS2008-12-04
BR10350840060TRULAB NClass II
BR10350840017UREIA FS*Class II
BR10350840010COLESTEROL FS*Class II

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