EPflex Feinwerktechnik GmbH.

Address:IM SCHWOELLBOGEN 24,DETTINGEN/ERMS Baden-Wurttemberg,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

Dislodger, Stone, Basket, Ureteral, Metal (FFL) (4)

Premarket Exempt

Yes

Clear

Domia Front - B937DOF1510 Catalog Number : DOF151

Device Description : Dormia 1.5Fr 11mm Stone Extractor

Device Class : 2

Duns Number: 312527765

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Domia Front - B937DOF1580 Catalog Number : DOF158

Device Description : Dormia 1.5Fr.8mm Stone Extractor

Device Class : 2

Duns Number: 312527765

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Domia Front - B937DOF2010 Catalog Number : DOF201

Device Description : Dormia 2Fr 11mm Stone Extractor

Device Class : 2

Duns Number: 312527765

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

Domia Front - B937DOF2080 Catalog Number : DOF208

Device Description : Dormia 2Fr 8mm Stone Extractor

Device Class : 2

Duns Number: 312527765

Premarket Exempt : Yes

Product Code : FFL

Prescription Use : Yes

Device Count : 1

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