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Devices for urogenital system
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Gynaecological devices
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Devices for assisted reproduction
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Substrates for storing/handling biological material for assisted reproduction
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Materials/solutions for preparation/handling for assisted reproduction
Materials/solutions for preparation/handling for assisted reproduction
U08020502
81 devices
Devices
Hypure® Oil
Kitazato Corporation
·
,
JP
Class IIa
CE/MDR
GUDID
on market
FertiCult Mineral Oil
FertiPro
·
,
BE
Class IIa
CE/MDR
GUDID
on market
Continuous Single Culture - NX Complete (CSCM-NXC)
Irvine Scientific, LLC
·
,
US
Class III
FDA 510(k)
K170602
Active
Cleared 7 Jun 2017
CE/MDD
+1
authorizations
FertiCult Mineral Oil
FertiPro
·
,
BE
Class IIa
CE/MDR
GUDID
on market
Human Serum Albumin (HSA)
Irvine Scientific, LLC
·
,
US
Class III
CE/MDD
GUDID
on market
GM501 Hyaluronidase 1 ml
Gynemed GmbH & Co. KG
·
,
DE
Class III
CE/MDD
GM501 PVP 1 ml
Gynemed GmbH & Co. KG
·
,
DE
Class III
CE/MDD
GM501 Mineral Oil
Gynemed GmbH & Co. KG
·
,
DE
Class IIa
CE/MDR
SpermCryoProtec
Nidacon International Ab
·
,
SE
Class III
FDA 510(k)
K023206
Active
Cleared 8 Nov 2002
CE/MDD
+1
authorizations
Hyaluronidase Solution
Irvine Scientific, LLC
·
,
US
Class III
CE/MDD
GUDID
on market
Hypure® Oil
Kitazato Corporation
·
,
JP
Class IIa
CE/MDR
GUDID
on market
FertiCult Mineral Oil
FertiPro
·
,
BE
Class IIa
CE/MDR
GUDID
on market
NidOil
Nidacon International Ab
·
,
SE
Class III
CE/MDD
GUDID
on market
Sil-Select Plus with phenol red and gentamicin - 16 preparations
FertiPro
·
,
BE
Class III
CE/MDR
Hypure® Oil
Kitazato Corporation
·
,
JP
Class IIa
CE/MDR
GUDID
on market
PureSperm 100
Nidacon International Ab
·
,
SE
Class III
CE/MDD
GUDID
on market
IVF Basics® Cult-Oil
Gynotec B.V.
·
,
NL
Class IIa
CE/MDD
FertiCult High Viscosity Oil
FertiPro
·
,
BE
Class IIa
CE/MDR
GUDID
on market
GM501 Flush 100 ml
Gynemed GmbH & Co. KG
·
,
DE
Class III
CE/MDD
FertiCult High Viscosity Oil
FertiPro
·
,
BE
Class IIa
CE/MDR
GUDID
on market
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