Dreve Otoplastik GmbH

Address:MAX-PLANCK-STR. 31,UNNA 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) (4) Kit, earmold, impression (LDG) (2)

Premarket Exempt

Yes

Clear

FotoTec® SL.A - E23975001 Catalog Number : 7500

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

FotoTec® Repair - E23975101 Catalog Number : 7510

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

FotoTec® Repair - E23976101 Catalog Number : 7610

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

FotoTec® SL.A - E2397800ST1 Catalog Number : 7800ST

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Otoform® A softX - E23988011 Catalog Number : 8801

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : LDG

Prescription Use : No

Device Count : 1

Otoform® A softX - E2398801M1 Catalog Number : 8801M

Device Description : No.

Device Class : 1

Duns Number: 315808340

Premarket Exempt : Yes

Product Code : LDG

Prescription Use : No

Device Count : 1

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