HomeNetherlandsUnitron Group B.V.

Unitron Group B.V.

Netherlands · Ijzendijke · www.unitron.nl
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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
0UDI-DI device records
USUnited StatesFDA openFDA
9listed device types
Class I 2Class II 7Class III 0
plus 7 registration records and 1 510(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
1valid device licences
Class I 1
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.

United States7 registration records, 1 510(k), 0 PMA, 4 excluded
United Kingdom0 confirmed, 1 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: UNITRON GROUP BV

Company information

Country
Netherlands
City
Ijzendijke
Website
www.unitron.nl
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)Components (MedTech, Manufacturing, etc.)

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

Legal name
Unitron Holding B.V.
LEI
724500ZFTWCYHN7SF024
Registration status
Active
Legal form
besloten vennootschap met beperkte aansprakelijkheid (BV)
Incorporated
1999-10-13
Registered address
Schansestraat 7, IJzendijke, 4515RN
Registration authority
Business Register, no. 22044089
Registry record updated
2022-09-09

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

11978 · K781616

FDA listed device types

showing 8 of 9
Gutta-Percha 1Retractor 1System, Perfusion, Kidney 1Amplifier And Signal Conditioner, Transducer Signal 1Warmer, Thermal, Infusion Fluid 1Catheter, Intravascular, Diagnostic 1Radiation Therapy Marking Device 1Pillow, Cervical (For Mild Sleep Apnea) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK781616OMNI STIK1978-12-08

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