MEDIPLUS LTD

Address:UNIT 7 THE GATEWAY CENTRE,HIGH WYCOMBE, BUCKS Buckinghamshire,GB

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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

ACCESSORIES, CATHETER (KGZ) (5) DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (5)

Premarket Exempt

No Yes

Clear

Mediplus - 05055140701732 Catalog Number :

Device Description : Damping tube set

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701749 Catalog Number :

Device Description : SetGuard

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701756 Catalog Number :

Device Description : Bladder filling catheter 10fr

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701763 Catalog Number :

Device Description : Bladder filling catheter 10fr soft

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701770 Catalog Number :

Device Description : Bladder filling catheter 6fr

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701787 Catalog Number :

Device Description : Bladder filling catheter 8fr

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701794 Catalog Number :

Device Description : Bladder filling catheter 12fr

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701800 Catalog Number :

Device Description : Urethral pressure profile catheter 8fr

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701831 Catalog Number :

Device Description : Triple lumen catheter, 9fr.

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140701848 Catalog Number :

Device Description : Triple lumen catheter, 9fr., short

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

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