HomeIndonesiaONEJECT INDONESIA, PT Corporate Legal Department

ONEJECT INDONESIA, PT Corporate Legal Department

Indonesia · Kab Bekasi · www.oneject.co.id
✓ Record-verifiedregistrations found in 4 marketsEU SRN ID-MF-000004875

This company has registrations in European Union, United States, Brazil, Canada — 4 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
68UDI-DI device records
Class IIa 68
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
2registered devices
Class I 2
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
2 including historic records
TWTaiwanTFDA
pendingnot queried
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 Union68 raw hits, 0 excluded, 68 confirmed
United States1 registration records, 0 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: PT ONEJECT INDONESIA

Regulatory identity

EU manufacturer SRN
ID-MF-000004875
EU authorised representative
Medical Technology Promedt Consulting GmbH

Company information

Country
Indonesia
City
Kab Bekasi
Website
www.oneject.co.id
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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 listed device types

Saline, Vascular Access Flush 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08990067036406SAFEJECT Disposable Syringe 3 ml with Safety Needle 22G x 1¼“Class IIa
EU08990067056855ONEJECT Hypodermic Syringe with Reuse Prevention Feature 5 ml 21G x 1 ½"Class IIa
EU08990067057388SAFEJECT Disposable Syringe Without Needle 5 mlClass IIa
EU08990067057371SAFEJECT Disposable Syringe Without Needle 3 mlClass IIa
BR80451960105nph medical seringa descartável com agulhaClass I
BR80451960120NPH MEDICAL SERINGA DESCARTÁVEL SEM AGULHAClass I

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