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

Otoscope (ERA) (6) Ophthalmoscope, Battery-Powered (HLJ) (4)

Premarket Exempt

Yes

Clear

zumax - 06945095511991 Catalog Number :

Device Description : Ophthalmoscope Bulb,3.5V

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095512004 Catalog Number :

Device Description : 3.5V Pro Coaxial Ophthalmoscope

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095516002 Catalog Number :

Device Description : 3.5V LED Coaxial Ophthalmoscope

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095520078 Catalog Number :

Device Description : OT8C Otoscope, handle,Zipper Bag

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

zumax - 06945095520788 Catalog Number :

Device Description : OT8C Otoscope head only

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

zumax - 06945095520955 Catalog Number :

Device Description : 2.5V LED bulb

Device Class : 2

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : HLJ

Prescription Use : No

Device Count : 1

zumax - 06945095520986 Catalog Number :

Device Description : otoscope bulb 2.5V

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

zumax - 06945095521006 Catalog Number :

Device Description : 3.5V Otoscope

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

zumax - 06945095521983 Catalog Number :

Device Description : Otoscope LED bulb,3.5V

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

zumax - 06945095521990 Catalog Number :

Device Description : Otoscope bulb,3.5V

Device Class : 1

Duns Number: 421348837

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

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