HomeGermanyPhilips Medizin Systeme Boblingen GmbH

Philips Medizin Systeme Boblingen GmbH

Germany · Boblingen
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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
13510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
15 including historic records
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
33active device licences
Class II 13Class III 20
106 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
21device registrations
CLASS B 2CLASS C 19
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
143active ARTG entries
Class I 60IIa 21IIb 62
HKHong KongMDACS
8valid listings
Class III 8
ILIsraelAMAR
13registrations
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 States0 registration records, 13 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Canada33 confirmed, 0 excluded
Manufacturer names merged into this page: PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH · Philips Medizin Systeme Boblingen GmbH
Same-named companies — This database also contains companies with near-identical names: Medizin Systeme Boblingen GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Boblingen

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

12001
22003
12004
12006
12008
12009
12010
12011
12012
12014
12015
12022

Registration details (sample)

MarketIdentifierNameClass / date
USK221141PageWriter TC35 Cardiograph2022-12-02
USK151736Philips IntelliVue GuardianSoftware2015-10-21
USK140535PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM502014-11-25
BR10216719035Estação de Trabalho Cardíaco – Cardiac WorkstationClass II
BR10216710222Eletrocardiógrafo PagewriterClass II
BR10216719030Eletrocardiógrafo PagewriterClass II
SAME0000009222SFDAA00003IntelliVue CL Charging Station
SAME0000009222SFDAA00004CBL Reusable EEG Pedi Cup Electrodes
CA1135NEONATAL HAND/FOOT SP02 SENSORClass II
CA6085ANESTHETIC GAS MONITOR CONNECTION SYSTEMClass II
CA12826NIBP (NON-INVASIVE BLOOD PRESSURE) MONITORING ACCESSORIESClass II

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