HomeUSAVR Medical, Inc.

VR Medical, Inc.

USA · Arcadia CA · www.vrmedical.net
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000032918

This company has registrations in European Union, United States, Brazil, Canada — 4 overseas markets. EU UDI-DI records ≥194, 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
≥194UDI-DI device records
Class I 1Class IIa 193
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
13listed device types
Class I 4Class II 9Class III 0
plus 15 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
768 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
8 including historic records
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 Union502 raw hits, 106 excluded, 194 confirmed. Large result set — only the first 300 verified
United States15 registration records, 5 510(k), 0 PMA, 3 excluded
United Kingdom0 confirmed, 13 excluded
Brazil1 confirmed, 1 excluded
Manufacturer names merged into this page: VR MEDICAL TECHNOLOGY CO., LTD. · VR MEDICAL TECHNOLOGY CO., LTD · VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA

Regulatory identity

EU manufacturer SRN
CN-MF-000032918
EU authorised representative
BioDomi GmbH

Company information

Country
USA
City
Arcadia CA
Website
www.vrmedical.net
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationTrauma systems

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 510(k) clearances by year

12011 · K110853
12014 · K132709
12016 · K162188
12017 · K162159
12019 · K180236

FDA listed device types

showing 8 of 13
Catheters, Suction, Tracheobronchial 1Condenser, Heat And Moisture (Artificial Nose) 1Dispenser, Liquid Medication 1Device, Fixation, Tracheal Tube 1Gastrointestinal Tubes With Enteral Specific Connectors 1Tube, Feeding 1Filter, Bacterial, Breathing-Circuit 1Catheter And Tip, Suction 1

Registration details (sample)

MarketIdentifierNameClass / date
EU16959180795149Class IIa
EU16959180795156Class IIa
EU16959180795163Class IIa
EU16959180795170Class IIa
USK180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)2019-01-18
USK162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing2017-04-28
USK162188Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)2016-09-22
BR80102511527Solução de Controle do Colesterol Mission®Class II

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