HomeGermanySpellman High Voltage Electronics GmbH

Spellman High Voltage Electronics GmbH

Germany · Bochum · www.spellmanhv.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN DE-MF-000014609

This company has registrations in European Union, United States — 2 overseas markets. EU UDI-DI records ≥300, 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
≥300UDI-DI device records
Class IIb 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 4 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
0valid device licences
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 Union304 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States4 registration records, 0 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: SPELLMAN HIGH VOLTAGE ELECTRONICS CORP. · SPELLMAN HIGH VOLTAGE ELECTRONICS(SUZHOU INDUSTRIAL PARK)CO.,LTD

Regulatory identity

EU manufacturer SRN
DE-MF-000014609
EU authorised representative
Spellman High Voltage Electronics GmbH

Company information

Country
Germany
City
Bochum
Website
www.spellmanhv.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

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
529900907I6H78G6OC41
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
2012-05-10
Registered address
Josef-Baumann-Str. 23, Bochum, 44805
Registration authority
Commercial Register, no. HRB 13916
Registry record updated
2026-03-05

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

FDA listed device types

Generator, High-Voltage, X-Ray, Diagnostic 1Assembly, Tube Housing, X-Ray, Diagnostic 1

Registration details (sample)

MarketIdentifierNameClass / date
EUESPN021523106BAHSS0 OptiX HF 60Class IIb
EUESPN021523106BA60 OptiX HF 60Class IIb
EUESPN021523106BA0 OptiX HF 60Class IIb
EUESPN031400108P0PROVARIO HF 80Class IIb

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