HomeNetherlandsBLUE MEDICAL BV

BLUE MEDICAL BV

Netherlands · Zaandam Noord-Holland
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia — 5 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
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 5Class II 3Class III 0
plus 8 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
181registered devices
Class I 25Class II 156
184 including historic records
SASaudi ArabiaSFDA
13registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 4
6 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
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.

United States8 registration records, 15 510(k), 0 PMA, 49 excluded
Brazil181 confirmed, 12 excluded
Saudi Arabia13 confirmed, 5 excluded
Canada4 confirmed, 6 excluded
Manufacturer names merged into this page: DEEP BLUE MEDICAL ADVANCES, INC. · BLUE CHIP MEDICAL PRODUCTS, INC. · BLUE DEER MEDICAL EQUIPMENT (GUANGDONG) CO., LTD. · BLUE MEDICAL BV · BLUE CHIP MEDICAL PRODUCTS,INC. · BLUE SAIL MEDICAL CO., LTD

Company information

Country
Netherlands
City
Zaandam Noord-Holland

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

11996
12003
22004
12005
12006
22007
12014
22017
12020
12022
22023

FDA listed device types

Mattress, Air Flotation, Alternating Pressure 1Mesh, Surgical, Polymeric 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Sling, Overhead Suspension, Wheelchair 1Surgical Table Cushion 1Mattress, Flotation Therapy, Non-Powered 1System, Pressure Measurement, Intermittent 1Guard, Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232924T-Line® Hernia Mesh2023-10-18
USK230227T-Line Hernia Mesh2023-02-23
USK221556T-Line Hernia Mesh2022-11-28
BR82090610005MÁSCARA TRIPLA TNT IIClass I
BR81818100012Luva Vinil Com PóClass I
BR80841790005LUVA DE LÁTEX PARA PROCEDIMENTOS NÃO CIRÚRGICOS SEM PÓ DERMASOFTClass I
SAME0000008936SFDAA00001YASHFEEN VINYL GLOVES
SAME0000008936SFDAA00002Sanita serv-u
CA71610POWER PRO TURN ELITE SYSTEMClass II
CA71611SUPREME AIR SYSTEMClass II
CA71608APOLLO 3-PORT SYSTEMClass II

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