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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Obstetrics and gynaecology instruments
Obstetrics and gynaecology instruments
Z1208
1,635 devices
Subcategories
5
Z120801
Prenatal diagnostic instruments
415
devices
›
Z120802
Gynaecology and fertility treatment instruments
210
devices
›
Z120803
Childbirth support and maternal assistance instruments
339
devices
›
Z120804
Neonatology instruments
648
devices
›
Z120899
Gynaecology and maternal-infants instruments - other
23
devices
Devices
Sonio Detect
Sonio
·
,
France
Class IIa
FDA 510(k)
×2
K230365
Active
Cleared 25 Jul 2023
CE/MDR
+1
authorizations
IntelliSpace Perinatal K Large Arch.
Philips Medizin Systeme Böblingen GmbH
·
,
Germany
Class IIa
CE/MDD
GUDID
on market
IntelliSpace Perinatal K Small Arch.
Philips Medizin Systeme Böblingen GmbH
·
,
Germany
Class IIa
CE/MDD
astraia – software for women's health - obstetric and gynaecological database a…
NEXUS / ASTRAIA GmbH
·
,
Germany
Class IIa
CE/MDR
FraiyaScan
Fraiya Ltd
·
,
United Kingdom
Class IIa
CE/MDR
SCAR-4.2.1.1
Active
Valid to Jul 2030
astraia – software for women's health
NEXUS / ASTRAIA GmbH
·
,
Germany
Class IIa
CE/MDR
Sonio Suspect
Sonio
·
,
France
Class IIa
FDA 510(k)
K243614
Active
Cleared 21 Feb 2025
CE/MDR
+1
authorizations
Trium CTG Online
Trium Analysis Online GmbH
·
,
Germany
Class IIb
CE/MDR
Sonio Detect
Sonio
·
,
France
Class IIa
CE/MDR
GUDID
on market
Sonicaid
Arjohuntleigh AB
·
,
Sweden
Class I
CE/MDR
mamivac® Hebammenstethoskop
Kimetec GmbH
·
,
Germany
Class I
CE/MDR
mamivac® Hebammenstethoskop
Kimetec GmbH
·
,
Germany
Class I
CE/MDR
mamivac® Hebammenstethoskop
Kimetec GmbH
·
,
Germany
Class I
CE/MDR
mamivac® Hebammenstethoskop
Kimetec GmbH
·
,
Germany
Class I
CE/MDR
NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10
Hologic
·
,
United States
Class IIb
CE/MDR
NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device
Hologic
·
,
United States
Class IIb
CE/MDR
Exhaust Collection Bag
Channel Medsystems, Inc.
·
,
United States
Class I
CE/MDR
GUDID
on market
Thermablate EAS
Idoman Teoranta
·
,
Ireland
Class IIb
CE/MDD
NovaSure Impedance Controlled Endometrial Ablation System Advanced Disposable D…
Hologic
·
,
United States
Class IIb
CE/MDR
OVUMPICK Ovum Pickup Needle
Allwin Medical Devices, Inc.
·
,
United States
Class IIa
CE/MDR
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