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BIONIME USA CORPORATION

Taiwan·TW-MF-000008450

Last updated September 17, 2026

Information

Country: Taiwan
Address: No. 100, Sec.2, Daqing St., South Dist., Taichung City, Taiwan
Website: bionime.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jessie Chen
EUDAMED SRN: TW-MF-000008450
FDA FEI Number: 3006755541
DUNS Number: —

Catalogue (102)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Rightest	GM550	FDA UDI	Class II	Active
Rightest	GS100	FDA UDI	Class II	Active
Rightest	GM250	FDA UDI	Class II	Active
Odm	Diathrive+ Bluetooth Blood Glucose Monitoring System	FDA UDI	Class II	Active
RIGHTEST GT333 Blood Glucose Test Strip	100PCS	FDA UDI	Class II	Active
RIGHTEST Wiz Blood Glucose Monitoring System	570G01	EUDAMED	IVD Annex II List B	Active
mylife AutoLance GD720 Lancing Devices	700023995	EUDAMED	Class I	Active
RIGHTEST Max Plus Blood Glucose Monitoring System	772G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST GT333 Blood Glucose Monitoring System	236G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Max Blood Glucose Monitoring System	770G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST ELSA Blood Glucose Monitoring System	111G01	EUDAMED	IVD Annex II List B	Active
Rightest Blood Glucose Monitoring System, Model Gm310	K072054	FDA 510(k)	Class II	Active
iGlucose Blood Glucose Monitoring System	K161790	FDA 510(k)	Class II	Active
Modification To Rightest Blood Glucose Monitoring System	K053635	FDA 510(k)	Class II	Active
Bionime Diabetes Management System Vi.0	K113007	FDA 510(k)	Class I	Active
Rightest Blood Glucose Monitoring System, Model Gm550	K092052	FDA 510(k)	Class II	Active
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,	K170143	FDA 510(k)	Class II	Active
Rightest Blood Glucose Monitoring System, Model Gm110	K081450	FDA 510(k)	Class II	Active
Rightest Blood Glucose Monitoring System, Model Gm100	K081451	FDA 510(k)	Class II	Active
Rightest Blood Glucose Monitoring System Gm700 Ge Ge200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin	K123008	FDA 510(k)	Class II	Active
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device	K221062	FDA 510(k)	Class II	Active
Rightest Blood Glucose Monitoring System	550G01	EUDAMEDFDA 510(k)	IVD Annex II List B	Active
Bionime Rightest GS300 Blood Glucose Test Strip	300G12	EUDAMED	IVD Annex II List B	Active
RIGHTEST Sol Blood Glucose Monitoring System	N700G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Alma Blood Glucose Monitoring System	N720G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Brisa Plus Blood Glucose Monitoring System	N722G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System	771K01	EUDAMED	IVD Annex II List B	Active
GE Blood Glucose Monitoring System GE100	555G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST ALPHA Blood Glucose Monitoring System	551G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST GM110 Blood Glucose Monitoring System	110G1	EUDAMED	IVD Annex II List B	Active
RIGHTEST Blood Glucose Monitoring System GM700S	780G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST GM100 Blood Glucose Monitoring System	100G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Blood Glucose Monitoring System GM280B	282G01	EUDAMED	IVD Annex II List B	Active
Bionime Rightest GS100 Blood Glucose Test Strip	100G12	EUDAMED	IVD Annex II List B	Active
Bionime Rightest Max Blood Glucose Test Strip	770G	EUDAMED	IVD Annex II List B	Active
RIGHTEST GD500 Lancing Device	R0B000	EUDAMED	Class I	Active
RIGHTEST Blood Glucose Monitoring System GM260	260G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Blood Glucose Monitoring System GM700	700G01	EUDAMED	IVD Annex II List B	Active
GE Blood Glucose Monitoring System GE200	280G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Brisa Blood Glucose Monitoring System	N710G01	EUDAMED	IVD Annex II List B	Active
Lancing Device	500D01	EUDAMED	Class I	Active
RIGHTEST Blood Glucose Monitoring System GM700SB	782G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Sol Plus Blood Glucose Monitoring System	N702G01	EUDAMED	IVD Annex II List B	Active
mylife Unio Neva Blood Glucose Monitoring System	722G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Blood Glucose Monitoring System GM300	300G01	EUDAMED	IVD Annex II List B	Active
Mylife Unio Cara Blood Glucose Monitoring System	775G01	EUDAMED	IVD Annex II List B	Active
Mobile Application For Blood Glucose Monitoring System	GP920	EUDAMED	IVD Annex II List B	Active
RIGHTEST Wiz Plus Blood Glucose Monitoring System	572G01	EUDAMED	IVD Annex II List B	Active
RIGHTEST Brisa Plus Blood Glucose Monitoring System	N712G01	EUDAMED	IVD Annex II List B	Active
mylife Softlance GD500 Lancing Devices	700023999	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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