HomeItalyChema Diagnostica Srl.

Chema Diagnostica Srl.

Italy · Monsano (AN) · www.chema.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN IT-MF-000009128

This company has registrations in European Union, Russia — 2 overseas markets. EU UDI-DI records ≥139, the first 300 verified individually. 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
≥139UDI-DI device records
IVD general 139
large result set — only the first 300 records were verified, so the real figure is at least this
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
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 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.

European Union412 raw hits, 161 excluded, 139 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 1 excluded
United Kingdom0 confirmed, 5 excluded

Regulatory identity

EU manufacturer SRN
IT-MF-000009128

Company information

Country
Italy
City
Monsano (AN)
Website
www.chema.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

Legal name
CHEMA DIAGNOSTICA SRL
LEI
815600FDA1B4C6DD6845
Registration status
Active
Legal form
Società A Responsabilità Limitata (SRL)
Incorporated
2020-12-29
Registered address
VIA CAMPANIA, 2/4, MONSANO, 60030
Registration authority
Business Register, no. 02872430422
Registry record updated
2026-05-27

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
EU08033650840261CK-MB FL IFCC/DGKCIVD general
EU08033650845884ASO FLIVD general
EU08033650846249ASO FLIVD general
EU08033650844603TRIGLYCERIDES FLIVD general

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