Zumax Medical Co., LTD

Zumax Medical Co., LTD

Address:5 ZHIYING STREET,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

Ophthalmoscope, Battery-Powered (HLJ) (7) Ophthalmoscope, Ac-Powered (HLI) (3)

Premarket Exempt

Yes

Clear

zumax - 06945095510000 Catalog Number :

Device Description : DM6C Ophthalmoscope Head

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095510192 Catalog Number :

Device Description : ophthalmoscope,B handle，Zipper Bag

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLI

Prescription Use : No

Device Count : 1

zumax - 06945095510253 Catalog Number :

Device Description : ophthalmocope bulb 2.5V

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095510789 Catalog Number :

Device Description : DM6C ophthalmoscope, handle，Zipper Bag

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095510888 Catalog Number :

Device Description : DM6C ophthalmoscope,rechargable Lithium handle，charger,Zipper Bag

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095511007 Catalog Number :

Device Description : 3.5V Coaxial Ophthalmoscope

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095511182 Catalog Number :

Device Description : Rechargable ophthalmoscope Set,with 489 handle，with DT801 charger，Zipper bag

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095511205 Catalog Number :

Device Description : Desk-top ophthalmoscope

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLI

Prescription Use : No

Device Count : 1

zumax - 06945095511304 Catalog Number :

Device Description : Wall Mount ophthalmoscope

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLI

Prescription Use : No

Device Count : 1

zumax - 06945095511984 Catalog Number :

Device Description : Ophthalmoscope LED Bulb,3.5V

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

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