GA Health Company Limited

Address:Unit 18, 21/F, Metropole Square,Hong Kong,HK

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Endoscopic Irrigation/Suction System (OCX) (5) Endoscope Channel Accessory (ODC) (4) Autonomous Extracorporeal Blood Leak Detector/Alarm (ODX) (1) Insufflator, Automatic Carbon-Dioxide For Endoscope (FCX) (1) Tubing/Tubing With Filter, Insufflation, Laparoscopic (NKC) (1)

Premarket Exempt

Yes No

Clear

andorate® CO2 Extend Tubing with Luer Connector - 04897106950201 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

andorate® CO2 Source Tubing Adapter - 04897106950218 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : Yes

Product Code : NKC

Prescription Use : Yes

Device Count : 1

andorate® Disposable Endoscope Valves Set - 04897106950225 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : ODC, OCX

Prescription Use : Yes

Device Count : 1

andorate® Disposable Endoscope Valves Set - 04897106950232 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

andorate® Suction Valve - 04897106950249 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

andorate® Air/Water Valve - 04897106950256 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Andorate® 4-piece Valve Kit - 04897106950263 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : ODX, OCX

Prescription Use : Yes

Device Count : 1

andorate® Disposable Biopsy Valve - 04897106950270 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

andorate® Disposable Biopsy Valve - 04897106950287 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

andorate® Disposable Endoscope Valves Set - 04897106950300 Catalog Number :

Device Class :

Duns Number: 686908512

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

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