HUNTLEIGH HEALTHCARE LIMITED

Address:DIAGNOSTIC PRODUCT DIVISION,CARDIFF, SOUTH GLAMORGAN,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

System, Monitoring, Perinatal (HGM) (5) Monitor, Ultrasonic, Fetal (KNG) (3) Sleeve, Limb, Compressible (JOW) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

SONICAID - 05051968041395 Catalog Number : SRX-USA

Device Description : USA DIG DOPPLER-ALKALINE-NO PROBE

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : KNG

Prescription Use : Yes

Device Count : 1

SONICAID - 05051968041401 Catalog Number : SR2-USA

Device Description : USA DIG DOPPLER-FIXED 2MHZ PROBE

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : KNG

Prescription Use : Yes

Device Count : 1

SONICAID - 05051968041418 Catalog Number : SR3-USA

Device Description : USA DIG DOPPLER-FIXED 3MHZ PROBE

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : KNG

Prescription Use : Yes

Device Count : 1

DOPPLEX - 05051968041852 Catalog Number : DISP10XS

Device Description : DIOP8 PROBE PK + PA8XS + POLE CLAMP

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : ITX

Prescription Use : Yes

Device Count : 1

OBIX - 05051968042057 Catalog Number : SF1-OBIX

Device Description : OBIX FREEDOM

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

OBIX - 05051968042071 Catalog Number : OBIX AM2N

Device Description : OBIX ANTEPARTUM-TWIN

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

OBIX - 05051968042972 Catalog Number : OBIX IM2 D

Device Description : OBIX INTRAPARTUM/NIBP+SPO2+EMHR+DVI TWINS

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

SONICAID - 05051968044020 Catalog Number : TEAM3A-EN-USA

Device Description : TEAM3 ANTEPARTUM/ECTG+NIBP USA

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

SONICAID - 05051968044037 Catalog Number : TEAM3A-ENB-USA

Device Description : TEAM3 ANTEPARTUM/ECTG+NIBP+BATTERY USA

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : HGM

Prescription Use : Yes

Device Count : 1

HYDROVEN - 05051968044198 Catalog Number : 510003US

Device Description : HYDROVEN 3 PUMP USA

Device Class : 2

Duns Number: 217207083

Premarket Exempt : No

Product Code : JOW

Prescription Use : Yes

Device Count : 1

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