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Devices for urogenital system
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Devices for urethral, ureteral and nephrostomic dilation
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Devices for urinary tract dilation - other
Devices for urinary tract dilation - other
U0399
50 devices
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Urology
SYNDEO Medical
·
,
Belgium
Class I
CE/MDR
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
U-Flex Duo Ureteral Access Sheath- Dual Lumen
Allwin Medical Devices, Inc.
·
,
United States
Class I
CE/MDR
Tahina 0.038" Nephrostomy Balloon Dilator
Envaste Ltd
·
,
Mauritius
Class IIa
CE/MDR
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Rps 30
Allium Ltd.
·
,
Israel
Class IIb
CE/MDD
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Tps Plus 40
Allium Ltd.
·
,
Israel
Class IIb
CE/MDD
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
×2
K251599
Active
Cleared 3 Jul 2025
CE/MDR
+1
authorizations
Tps Plus 60
Allium Ltd.
·
,
Israel
Class IIb
CE/MDD
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDR
GUDID
on market
U-Flex Ureteral Access Sheath
Allwin Medical Devices, Inc.
·
,
United States
Class I
CE/MDR
Navigator™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Tahina 0.038" Nephrostomy Balloon Dilator
Envaste Ltd
·
,
Mauritius
Class IIa
CE/MDR
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