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PT. PRIME BIOTECH INDONESIA

Indonesia · Jakarta · www.primebiotechmed.com

✓ Record-verifiedregistrations found in 2 marketsEU SRN ID-MF-000037746

This company has registrations in European Union, United Kingdom — 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

85UDI-DI device records

Class I 17Class IIa 68

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIa 4

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

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 Union85 raw hits, 0 excluded, 85 confirmed

United States0 registration records, 0 510(k), 0 PMA, 23 excluded

United Kingdom4 confirmed, 0 excluded

Brazil0 confirmed, 7 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Regulatory identity

EU manufacturer SRN: ID-MF-000037746
EU authorised representative: MedNet EC-REP GmbH
UK responsible person: Nipro Medical UK Ltd

Business registration

Legal name: PT FIRMENICH INDONESIA
LEI: 549300SYXIYB5NQM3H75
Registration status: Active
Legal form: Perseroan Terbuka (Tbk)
Incorporated: 2016-12-31
Registered address: JL.TANAH ABANG II /78, KEL.CIDENG, KEC. GAMBIR, JAKARTA, 10150
Registration authority: Company Registry, no. 8120211181834
Registry record updated: 2026-01-30

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08990060700298	—	Class I
EU	08990060700458	Electric stretcher	Class I
EU	08990060700441	Electric stretcher	Class I
EU	08990067036406	SAFEJECT Disposable Syringe 3 ml with Safety Needle 22G x 1¼“	Class IIa
UK	47017	Reladose syringe	Class IIa
UK	63095	Precision Syringe 0.3mL	Class IIa
UK	34999	Nipro Blood Tubing Set	Class IIa

PT. PRIME BIOTECH INDONESIA

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

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