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Single-use Flexible Cystoscope

SUV-1D-B, SUV-1D-P, SUV-3D-B, SUV-4D-B

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381254273
Basic UDI-DI: 697138125041A8K
Reference: SUV-1D-B
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Belgium
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

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Single-use Hystero Videoscope

SHV-S1，SHV-S2

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381253740
Basic UDI-DI: 697138125030A8B
Reference: SHV-S1
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Belgium
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

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Single-use Hystero Videoscope

SHV-4800, SHV-6800, SHV-4830, SHV-4830L, SHV-4830N, SHV-4830LN, SHV-6830, SHV-6830L, SHV-6830N, SHV-6830LN, SHV-5830, SHV-5830L, SHV-5830N, SHV-5830LN

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381253726
Basic UDI-DI: 697138125029A8Z
Reference: SHV-4800
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Belgium
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:55

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Single-use Hystero Videoscope

SHV-B1,SHV-P1,SHV-B2,SHV-P2

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250817
Basic UDI-DI: 697138125012A87
Reference: SHV-B1
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

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Single-use Urology Videoscope

SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-B

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250374
Basic UDI-DI: 697138125007A8H
Reference: SUV-1A-B
EMDN: Z12020709
EMDN description: UTEROSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

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Single use flexible cystoscope

CY-D1,CY-F1

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355350970
Basic UDI-DI: 69713553502158B
Reference: CY-D1
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:50

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Single use flexible ureteroscope

UR-D1,UR-D2,UR-F1,UR-F2

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355350673
Basic UDI-DI: 69713553502088E
Reference: UR-D1
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:50

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Single use hysteroscope

HY-G1

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355350246
Basic UDI-DI: 69713553502398R
Reference: HY-G1
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Belgium
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:50

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06971244213478

ZG-2/ZG-3

Class IIaMDR 2017/745Not intended for EU marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244213478
Basic UDI-DI: 697124421GQJ0002CK
Reference: J1330E
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: -
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

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06971244213355

XG-5/XG-5A/ZG-1

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244213355
Basic UDI-DI: 697124421GQJ0001CH
Reference: J0122
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

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06971244212150

QD-2

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244212150
Basic UDI-DI: 697124421DQJ0001AW
Reference: J0330H
EMDN: Z12020707
EMDN description: RESECTOSCOPES
First on market country: Northern Ireland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

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06971244210682

NP-3

Class IIaMDR 2017/745Not intended for EU marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244210682
Basic UDI-DI: 697124421PGJ0001D8
Reference: J0300E
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: -
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:45

Manufacturer products Authorised representative products Authorised representative actors View details

MDH

MC100

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000009220
UDI-DI: 06971176281088
Basic UDI-DI: 697117628HDU
Reference: MC100 (Standard Deflection; English)
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Cyprus
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

06971176281040

PC200-AS, PC200-AR, PC200-S, PC200-R;

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000009220
UDI-DI: 06971176281040
Basic UDI-DI: 697117628BDG
Reference: PC200-AS
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Sweden
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Uscope

PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; PU500-AS, PU500-AR, PU501-AS, PU501-AR;

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000009220
UDI-DI: 06971176280012
Basic UDI-DI: 697117628ADE
Reference: PU3022 (Reverse Deflection)
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

Single-Use Digital Flexible Ureteroscope

ZSR-URS-01、ZSR-URS-02、ZSR-URS-03、ZSR-URS-04

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Dongguan ZSR Biomedical Technology Company Limited
Manufacturer SRN: CN-MF-000016828
UDI-DI: 06936345105749
Basic UDI-DI: 69363451ZSRURS012F7
Reference: ZSR-URS-01
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 10:06

Manufacturer products Authorised representative products Authorised representative actors View details

06932619742788

Single-Use Flexible Video Cystoscope

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Transmed (China) Co., Ltd.
Manufacturer SRN: CN-MF-000029614
UDI-DI: 06932619742788
Basic UDI-DI: 69326197FC61728AS
Reference: G08001
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

LithoVue™

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506067496
Basic UDI-DI: 01915060000000000000579NY
Reference: M00679400010
EMDN: Z12020709
EMDN description: UTEROSCOPES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

LithoVue™

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506067502
Basic UDI-DI: 01915060000000000000579NY
Reference: M00679405010
EMDN: Z12020709
EMDN description: UTEROSCOPES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Ambu® aScope 5 Uretero

Ambu aScope 5 Uretero

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Ambu A/S
Manufacturer SRN: DK-MF-000001437
UDI-DI: 05707480157464
Basic UDI-DI: 570748030101041006S
Reference: 605001000
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:36

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