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 - EPRCA0031690 Catalog Number : A0031690

Device Description : ES-1.1 / 40 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

otosil ES-1.1 - EPRCA0031776 Catalog Number : A0031776

Device Description : ES-1.1 / 40 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 - EPRCA0031828 Catalog Number : A0031828

Device Description : ES-1.1 / 40 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 - EPRCA0031930 Catalog Number : A0031930

Device Description : ES-1.1 / 40 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 - EPRCA0032027 Catalog Number : A0032027

Device Description : ES-1.1 / 40 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 - EPRCA0032129 Catalog Number : A0032129

Device Description : ES-1.1 / 40 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

PRO3DURE ES-1.1 - EPRCA0032200 Catalog Number : A0032200

Device Description : ES-1.1 / Shore 40 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 - EPRCA0032303 Catalog Number : A0032303

Device Description : ES-1.1 / 40 Shore neon-pink 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 - EPRCA0032528 Catalog Number : A0032528

Device Description : ES-1.1 / 40 Shore light-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 - EPRCA0032727 Catalog Number : A0032727

Device Description : ES-1.1 / 40 Shore neon-orange 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

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