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

MONITOR, ESOPHAGEAL MOTILITY, AND TUBE (KLA) (6) ACCESSORIES, CATHETER (KGZ) (3) DEVICE, CYSTOMETRIC, HYDRAULIC (FEN) (1)

Premarket Exempt

No Yes

Clear

Mediplus - 05055140700506 Catalog Number :

Device Description : 8 channel antroduodenal catheter, 3.9mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700513 Catalog Number :

Device Description : 8 channel antroduodenal catheter, 3.9mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700520 Catalog Number :

Device Description : 8 channel antroduodenal catheter, 3.9mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700537 Catalog Number :

Device Description : 8 channel antroduodenal catheter, 2.3mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700582 Catalog Number :

Device Description : 4 channel vector anorectal catheter, 4.5mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700629 Catalog Number :

Device Description : Pump tube set for urodynamics system - Laborie

Device Class : 2

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : FEN

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700636 Catalog Number :

Device Description : 8 channel antroduodenal catheter, 3.9mm

Device Class : 2

Duns Number: 228480810

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700681 Catalog Number :

Device Description : Cystometry 6fr & rectal catheter with introducer set

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700728 Catalog Number :

Device Description : Cystometry 8fr & rectal catheter set

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

Mediplus - 05055140700742 Catalog Number :

Device Description : Cystometry 6fr & rectal catheter set

Device Class : 1

Duns Number: 228480810

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

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