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Philosys, Inc.

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Gmate® Control Solution Level 3	PC-003	FDA UDI	Class I	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Gmate® Control Solution Level 2	PC-002	FDA UDI	Class I	Active
GlucoTrack Solution Level 3	GT-C03	FDA UDI	Class I	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Pip Control Solution Normal	PC002-US	FDA UDI	Class I	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
Gmate® STEP Blood Glucose Monitoring System	PG-201	FDA UDI	Class II	Active
GlucoTrack Blood Glucose Test Strips	GT-S01	FDA UDI	Class II	Active
Pip Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
GlucoTrack VOICE Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
GlucoTrack Solution Level 1	GT-C01	FDA UDI	Class I	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
Gmate® Origin Blood Glucose Monitoring System	PG-310	FDA UDI	Class II	Active
GlucoTrack Solution Level 2	GT-C02	FDA UDI	Class I	Active
Gmate® Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
Gmate Smart Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Pip Control Solution Low	PC001-US	FDA UDI	Class I	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Gmate® mini Blood Glucose Monitoring System	PG-200	FDA UDI	Class II	Active
Pip Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
Gmate® Blood Glucose Test Strips	PS-004	FDA UDI	Class II	Active
GlucoTrack Blood Glucose Test Strips	GT-S01	FDA UDI	Class II	Active
GlucoTrack VOICE Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
Gmate® SMART Blood Glucose Monitoring System	PG-101	FDA UDI	Class II	Active
GlucoTrack SMART Blood Glucose Monitoring System	GT-101	FDA UDI	Class II	Active
GlucoTrack Voice Blood Glucose Monitoring System	GT-301	FDA UDI	Class II	Active
Gmate® VOICE Blood Glucose Monitoring System	PG-301	FDA UDI	Class II	Active
Pip Control Solution High	PC003-US	FDA UDI	Class I	Active
Gmate® Control Solution Level 1	PC-001	FDA UDI	Class I	Active
Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System	K141656	FDA 510(k)	Class II	Active
Blood Glucose Monitoring System (glucose Oxidase)	K113636	FDA 510(k)	Class II	Active
Gmate SMART Blood Glucose Monitoring System	K150299	FDA 510(k)	Class II	Active
Gmate Origin Blood Glucose Monitoring System	K151658	FDA 510(k)	Class II	Active
Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application	K131230	FDA 510(k)	Class II	Active

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