HomeGermanyIBA Dosimetry GmbH

IBA Dosimetry GmbH

Germany · Schwarzenbruck · www.iba-dosimetry.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN DE-MF-000006225

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 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
144UDI-DI device records
Class I 8Class IIb 136
USUnited StatesFDA openFDA
6listed device types
Class I 3Class II 3Class III 0
plus 18 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
10registered device records
Class I 5Class IIb 5
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
8active device licences
Class II 8
35 including historic records
TWTaiwanTFDA
6valid device licences
Class II 6
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 2IIb 3Class Im (measuring) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
7registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union145 raw hits, 1 excluded, 144 confirmed
United States18 registration records, 3 510(k), 0 PMA, 3 excluded
United Kingdom10 confirmed, 1 excluded
Saudi Arabia6 confirmed, 0 excluded
Canada8 confirmed, 0 excluded
Manufacturer names merged into this page: IBA Dosimetry GmbH · IBA Dosimetry America · IBA DOSIMETRY AB · IBA DOSIMETRY GMBH · IBA DOSIMETRY GMBH.

Regulatory identity

EU manufacturer SRN
DE-MF-000006225
UK responsible person
Oncology Systems Limited
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
Germany
City
Schwarzenbruck
Employees
1000–5000
Annual revenue
RMB 100–500M
Company type
Manufacturer
Website
www.iba-dosimetry.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineNuclear Medicine & Molecular ImagingDosimetry & radiation safety

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.

Business registration

LEI
529900M290M67LNH3P49
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1979-10-25
Registration authority
Commercial Register, no. HRB 4262
Registry record updated
2026-03-13

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12009 · K092018
22020 · K201798

FDA listed device types

Accelerator, Linear, Medical 1System, Radiation Therapy, Charged-Particle, Medical 1Accessory - Film Dosimetry System 1Medical Device Data System 1Phantom, Anthropomorphic, Radiographic 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

MarketIdentifierNameClass / date
EUEIBADP310000myQA PhoenixClass I
EUEIBA999702BT0PFD FIELD DetectorClass IIb
EUEIBA999802BT0RFD Reference DetectorClass IIb
EUEIBA9640040EDP-20 INVIVO DetectorClass IIb
UK38399Dosimetry SystemsClass IIb
UK38399Accelerator system quality assurance deviceClass IIb
UK38399Dosimetry SystemsClass I
USK201798myQA iON2020-07-17
USK191821Blue Phantom PT2020-01-23
USK092018OMNIPRO INCLINE2009-09-18
SAME0000006584SFDAA00015Sphinx
SAME0000006584SFDAA00022Gantry Sensor+
CA64684I`MRT QAClass II
CA64689WATER PHANTOMClass II
CA64690DOSE1 DOSIMETERClass II

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