MEDOVATE LIMITED

Address:The Workplace, Camboro Business Park,Cambridge Cambridgeshire,GB

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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

Pump, Infusion (FRN) (5)

Premarket Exempt

Clear

SAFIRA - 05060727270013 Catalog Number : 900044

Device Description : SAFIRA system foot operator for controlling SAFIRA Driver

Device Class : 2

Duns Number: 223136416

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

SAFIRA - 05060727270020 Catalog Number : 900029

Device Description : SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA opera SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA operators and SAFIRA Syringes

Device Class : 2

Duns Number: 223136416

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

SAFIRA - 05060727270037 Catalog Number : 900016

Device Description : Sterile SAFIRA 20 mL syringe (Luer)

Device Class : 2

Duns Number: 223136416

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

SAFIRA - 05060727270051 Catalog Number : 900058

Device Description : Sterile SAFIRA 20 mL syringe (NRFit)

Device Class : 2

Duns Number: 223136416

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

SAFIRA - 05060727270068 Catalog Number : 900059

Device Description : SAFIRA System hand operator for controlling SAFIRA Driver

Device Class : 2

Duns Number: 223136416

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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