HomeGermanyEuromed Biotech GmbH

Euromed Biotech GmbH

Germany · Dresden · www.euromed-biotech.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN IT-MF-000035447

This company has registrations in European Union, Brazil — 2 overseas markets. EU UDI-DI records ≥1, 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
≥1UDI-DI device records
Class I 1
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
4registered devices
Class II 4
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
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 Union621 raw hits, 299 excluded, 1 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
United Kingdom0 confirmed, 1 excluded
Brazil4 confirmed, 2 excluded
Saudi Arabia0 confirmed, 4 excluded
Manufacturer names merged into this page: EUROMED BIOTECH CO.,LTD.

Regulatory identity

EU manufacturer SRN
IT-MF-000035447

Company information

Country
Germany
City
Dresden
Website
www.euromed-biotech.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & 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.

Registration details (sample)

MarketIdentifierNameClass / date
EU08052859600001Class I
BR10230730218ez Adenovirus Rapid TestClass II
BR10230730219ez RSV Rapid TestClass II
BR10230730220ez Rotavirus Rapid TestClass II

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