HomeSwedenBOULE MEDICAL AB

BOULE MEDICAL AB

Sweden · Spanga Stockholm
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Israel, Russia — 7 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
5listed device types
Class I 4Class II 1Class III 0
plus 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
15registered devices
Class I 7Class II 8
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
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
13active registrations
Class 1 2Class 2a 11
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 States5 registration records, 2 510(k), 0 PMA
Brazil15 confirmed, 0 excluded
Manufacturer names merged into this page: BOULE MEDICAL AB

Company information

Country
Sweden
City
Spanga Stockholm

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

12004 · K032214
12009 · K083420

FDA listed device types

Counter, Differential Cell 1Diluent, Blood Cell 1Products, Red-Cell Lysing Products 1Detergent 1Tube, Collection, Capillary Blood 1

Registration details (sample)

MarketIdentifierNameClass / date
USK083420MEDONIC M SERIES2009-02-03
USK032214MEDONIC CA620/530 HEMATOLOGY ANALYZER2004-01-29
BR81298810012BOULE MPA MICRO PIPETTES PLASTIC (BOULE MICROPIPETA MPA PLÁSTICA)Class I
BR10009010162SDH 20Class II
BR81298810064Swelab Lumi-L1 Lyse (Lisante)Class I

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