Smartdata Suzhou Co., Ltd.

Smartdata Suzhou Co., Ltd.

Address:F4, Building 7, 198 Jinshan Rd,Suzhou Jiangsu,CN

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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) (6) Endoscope Channel Accessory (ODC) (2) Trap, Sterile Specimen (BYZ) (2)

Premarket Exempt

No Yes

Clear

Andorate® - 06970661240333 Catalog Number :

Device Class :

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Andorate® - 06970661241033 Catalog Number :

Device Class :

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Andorate® - 06970661241491 Catalog Number :

Device Class :

Duns Number: 529507479

Premarket Exempt : Yes

Product Code : BYZ

Prescription Use : Yes

Device Count : 1

Andorate - 06970661241538 Catalog Number :

Device Class : 2

Duns Number: 529507479

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

Andorate® - 06970661241545 Catalog Number :

Device Class :

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

AquaPulse - 06970661241552 Catalog Number :

Device Description : Auxiliary Water Connector

Device Class : 2

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Andorate - 06970661241583 Catalog Number :

Device Description : Disposable Endoscope Valves Set

Device Class : 2

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

Andorate® - 06970661241736 Catalog Number :

Device Class :

Duns Number: 529507479

Premarket Exempt : Yes

Product Code : BYZ

Prescription Use : Yes

Device Count : 1

Andorate - 06970661241781 Catalog Number :

Device Description : Disposable Endoscopes Valves Set

Device Class : 2

Duns Number: 529507479

Premarket Exempt : No

Product Code : ODC

Prescription Use : Yes

Device Count : 1

AquaPulse - 06970661241828 Catalog Number :

Device Description : Auxiliary Water Connector

Device Class : 2

Duns Number: 529507479

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

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