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 - EPRCA0033703 Catalog Number : A0033703

Device Description : ES-1.1 / 60 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 - EPRCA0033928 Catalog Number : A0033928

Device Description : ES-1.1 / 60 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 - EPRCA0034127 Catalog Number : A0034127

Device Description : ES-1.1 / 60 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

PRO3DURE GR-1 - EPRCA1000200 Catalog Number :

Device Description : audioprint INR-1

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

audioprint INR-1 - EPRCA1000202 Catalog Number : A1000202

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

audioprint INR-1 - EPRCA1000204 Catalog Number : A1000204

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

audioprint INR-1 - EPRCA1000205 Catalog Number : A1000205

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

audioprint INR-1 - EPRCA1000206 Catalog Number : A1000206

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

audioprint INR-1 - EPRCA1000208 Catalog Number : A1000208

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

audioprint INR-1 - EPRCA1000212 Catalog Number : A1000212

Device Description : audioprint INR-1 Generative resin for production of earpieces

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

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