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VersaVue™ Single-Use Flexible Cystoscope (Reverse, single pack)

EUC 100

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Medimaging Integrated Solution Inc
Manufacturer SRN: TW-MF-000009317
UDI-DI: 04719872715153
Basic UDI-DI: 47198727150018R
Reference: M0067801510
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Netherlands
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

CST-5000i Series Video Cystoscope/Hysteroscope, NTSC

08-5203

Class IIaMDDOn the market

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485001278
Basic UDI-DI: B-00874485001278
Reference: 08-5203
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 01.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

CST-5000i Series Video Cystoscope/Hysteroscope, PAL

08-5204

Class IIaMDDOn the market

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485001261
Basic UDI-DI: B-00874485001261
Reference: 08-5204
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 01.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

CST-5000 Series Video Cystoscope/Hysteroscope, NTSC

08-5201

Class IIaMDDOn the market

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485000882
Basic UDI-DI: B-00874485000882
Reference: 08-5201
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 01.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

CST-5000 Series Video Cystoscope/Hysteroscope, PAL

08-5202

Class IIaMDDOn the market

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485000875
Basic UDI-DI: B-00874485000875
Reference: 08-5202
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 01.08.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details

CystoFlex™ R N

UroFlex™ N

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: MAUNA KEA TECHNOLOGIES
Manufacturer SRN: FR-MF-000000835
UDI-DI: 03760187912042
Basic UDI-DI: 376018791NCM6E7
Reference: FP-10032
EMDN: Z12020785
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 01.08.2026 04:13

Manufacturer products View details

UroFlex™ N

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: MAUNA KEA TECHNOLOGIES
Manufacturer SRN: FR-MF-000000835
UDI-DI: 03760187912097
Basic UDI-DI: 376018791NCM6E7
Reference: FP-10037
EMDN: Z12020785
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 04:13

Manufacturer products View details

CystoFlex™ F N

Class IIaNot specifiedOn the marketDirect marking

Manufacturer: MAUNA KEA TECHNOLOGIES
Manufacturer SRN: FR-MF-000000835
UDI-DI: 03760187912103
Basic UDI-DI: 376018791NCM6E7
Reference: FP-10038
EMDN: Z12020785
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 04:13

Manufacturer products View details

COLPOSCREEN

VIDEOCOLPOSCOPE

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041581499
Basic UDI-DI: 84360415801152K
Reference: 19657001
EMDN: Z1202070801
EMDN description: VIDEO COLPOSCOPY SYSTEMS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:50

Manufacturer products View details

OP-C12

Colposcope

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041580089
Basic UDI-DI: 84360415801112B
Reference: 19503007
EMDN: Z12020703
EMDN description: COLPOSCOPES
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

06903053111522

FCY08-L069BAF

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: WUHAN MINDRAY SCIENTIFIC CO., LTD.
Manufacturer SRN: CN-MF-000032692
UDI-DI: 06903053111522
Basic UDI-DI: 697728811A065000219C
Reference: \
EMDN: Z12020711
EMDN description: VIDEO CYSTOURETHROSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

06903053089432

FUR08-L068BBF

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: WUHAN MINDRAY SCIENTIFIC CO., LTD.
Manufacturer SRN: CN-MF-000032692
UDI-DI: 06903053089432
Basic UDI-DI: 697728811A0650001097
Reference: FUR08-L068PBF
EMDN: Z12020709
EMDN description: UTEROSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:49

Manufacturer products Authorised representative products Authorised representative actors View details

Renal Pressure Monitoring Processor

HV-M200

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Anhui Happiness Workshop Medical Instruments Co., Ltd
Manufacturer SRN: CN-MF-000007232
UDI-DI: 06972498493487
Basic UDI-DI: 6972498490700G3
Reference: HV-M200
EMDN: Z12020799
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS – OTHER
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

06955797773511

UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Unimicro Medical Systems (Shenzhen) Co., Ltd
Manufacturer SRN: CN-MF-000014590
UDI-DI: 06955797773511
Basic UDI-DI: 69557977UNEN003DG
Reference: UNEN-BD50A
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

06955797773313

UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Unimicro Medical Systems (Shenzhen) Co., Ltd
Manufacturer SRN: CN-MF-000014590
UDI-DI: 06955797773313
Basic UDI-DI: 69557977UNEN002DE
Reference: UNC-UT31A
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

UHD Imaging System for Endoscope/ FHD Imaging System for Endoscope

4K-A1-101（A）

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Guangdong Softlink Medical Innovation Co.,Ltd.
Manufacturer SRN: CN-MF-000025833
UDI-DI: 06949567063018
Basic UDI-DI: 694956700001M6
Reference: 4K-A1-101（A）
EMDN: Z12020703
EMDN description: COLPOSCOPES
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 20:14

Manufacturer products Authorised representative products Authorised representative actors View details

06945014205765

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Zhejiang Tiansong Medical Instrument Co.,Ltd
Manufacturer SRN: CN-MF-000008834
UDI-DI: 06945014205765
Basic UDI-DI: 69450142Z120207A28
Reference: A0210
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

06945014205055

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Zhejiang Tiansong Medical Instrument Co.,Ltd
Manufacturer SRN: CN-MF-000008834
UDI-DI: 06945014205055
Basic UDI-DI: 69450142Z120207B2A
Reference: A0011.3
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

06945014204966

Class IIaMDR 2017/745On the marketReusable

Manufacturer: Zhejiang Tiansong Medical Instrument Co.,Ltd
Manufacturer SRN: CN-MF-000008834
UDI-DI: 06945014204966
Basic UDI-DI: 69450142Z120207C2C
Reference: A0010
EMDN: Z12020701
EMDN description: CYSTOSCOPES
First on market country: Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:02

Manufacturer products Authorised representative products Authorised representative actors View details

06937440449592

Disposable Digital Flexible Ureteroscope

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Zhejiang YiGao Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000032913
UDI-DI: 06937440449592
Basic UDI-DI: 69368888AFU001V7
Reference: AFU07536B-YGEU
EMDN: Z12020713
EMDN description: URETERORENOSCOPES
First on market country: Ireland
Authorised representative: TRANSMED GLOBAL CONSULTING, S.L.
Last updated: 31.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details