WIPRO GE HEALTHCARE PRIVATE LIMITED

Address:122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO,BANGALORE Karnataka,IN

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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

SYSTEM, MONITORING, PERINATAL (HGM) (7) CABLE, ELECTRODE (IKD) (1) MONITOR, HEART RATE, FETAL, ULTRASONIC (HEL) (1) MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) (HFM) (1)

Premarket Exempt

No Yes

Clear

Mini Telemetry System - 00840682117012 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117067 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117081 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117111 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117128 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117166 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

Mini Telemetry System - 00840682117173 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

ULTRASOUND TRANSDUCER - 00840682142564 Catalog Number : 2108346

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HEL

Prescription Use : Yes

Device Count : 1

TOCO TRANSDUCER - 00840682142571 Catalog Number : 2108347

Device Class : 2

Duns Number: 650140403

Premarket Exempt : No

Product Code : HFM

Prescription Use : Yes

Device Count : 1

Coro - Round MECG cable AHA - 00840682143240 Catalog Number :

Device Class : 2

Duns Number: 650140403

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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