pro3dure medical GmbH

Address:Am Burgberg 13,Iserlohn North Rhine-Westphalia,DE

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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

Hearing Aid, Air Conduction (ESD) (10)

Premarket Exempt

No Yes

Clear

otosil ES-1.1 - EPRCA0032900 Catalog Number : A0032900

Device Description : ES-1.1 / 60 Shore white opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033003 Catalog Number : A0033003

Device Description : ES-1.1 / 60 Shore reddish-transparent 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033004 Catalog Number : A0033004

Device Description : ES-1.1 / 60 Shore violet 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033176 Catalog Number : A0033176

Device Description : ES-1.1 / 60 Shore black-opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033228 Catalog Number : A0033228

Device Description : ES-1.1 / 60 Shore dark-blue opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033330 Catalog Number : A0033330

Device Description : ES-1.1 / 60 Shore neon-green opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033427 Catalog Number : A0033427

Device Description : ES-1.1 / 60 Shore red opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033529 Catalog Number : A0033529

Device Description : ES-1.1 / 60 Shore neon-yellow opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033600 Catalog Number : A0033600

Device Description : ES-1.1 / 60 Shore clear-transparent 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0033690 Catalog Number : A0033690

Device Description : ES-1.1 / 60 Shore smoke-grey8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

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