HomeGermanyUniray Medical GmbH

Uniray Medical GmbH

Germany · Wuppertal · uniraymedical.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN IN-MF-000028870

This company has registrations in European Union, United States, Brazil — 3 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
25UDI-DI device records
Class I 25
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
8registered devices
Class I 6Class II 2
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
0valid device licences
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 Union25 raw hits, 0 excluded, 25 confirmed
United States5 registration records, 0 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Manufacturer names merged into this page: Uniray Medical LLP · UNIRAY MEDICAL LLP

Regulatory identity

EU manufacturer SRN
IN-MF-000028870
EU authorised representative
CMC Medical Devices & Drugs SL

Company information

Country
Germany
City
Wuppertal
Website
uniraymedical.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

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.

FDA listed device types

Device, Digital Image Storage, Radiological 1Radiographic Protective Glove 1Shield, Eye, Radiological 1Shield, Protective, Personnel 1Apron, Protective 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08904333234144UNIRAYClass I
EU08904333240404UNIRAYClass I
EU08904333234021UNIRAYClass I
EU08904333246666UNIRAYClass I
BR80505620007LUVA ESTÉRIL PROTETIVA AOS RAIOS IONIZANTESClass I
BR80505620006Campo de Proteção Radiológica RadBlockClass I
BR10358460007VESTIMENTAS DE PROTEÇÃO RADIOLÓGICA UNIRAYClass I

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