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Bionime Corporation

✓ Record-verifiedregistrations found in 8 marketsEU SRN TW-MF-000008450

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

57UDI-DI device records

Class I 5Class IIa 5Class IIb 10IVD C 1ivd-annex-ii-list-b 36

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 12 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD Annex II List B 1

BRBrazilANVISA

1registered devices

Class I 1

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

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IVD Class 3 1

HKHong KongMDACS

2valid listings

IVD C 2

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 Union57 raw hits, 0 excluded, 57 confirmed

United States12 registration records, 21 510(k), 0 PMA, 2 excluded

United Kingdom1 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: BIONIME CORPORATION

Regulatory identity

EU manufacturer SRN: TW-MF-000008450
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

FDA 510(k) clearances by year

12005

12006

12007

32008

12010

32012

22013

12014

22017

22018

12019

12022

22024

FDA listed device types

Glucose Dehydrogenase, Glucose 1Multiple Use Blood Lancet For Single Patient Use Only 1Glucose Oxidase, Glucose 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04710949332693	mylife Softlance Lancing Devices	Class I
EU	D-GM550UC	Rightest Blood Glucose Monitoring System	ivd-annex-ii-list-b
EU	D-GM720UD	RIGHTEST Blood Glucose Monitoring System GM720	ivd-annex-ii-list-b
EU	D-GM722UH	mylife Unio Neva Blood Glucose Monitoring System	ivd-annex-ii-list-b
UK	62537	mylife Pura BGM Control Solution	IVD Annex II List B
US	K240637	RIGHTEST Blood Glucose Monitoring System Max Tel	2024-11-04
US	K231192	RIGHTEST Blood Glucose Monitoring System Max Tel	2024-01-19
US	K221062	RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device	2022-09-26
BR	10410619005	LANCETADOR RIGHTEST GD 500	Class I

Bionime Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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