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Class IIINot specifiedOn the marketSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014457702
Basic UDI-DI: 69560144CCBDCKH
Reference: 635770
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-VBC-001 · Rev. 01
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Intravascular Lithotripsy Generator and Connector Cable

Class IIbMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499689
Basic UDI-DI: 69560144ILGCT2
Reference: 629968
EMDN: Z120602
EMDN description: PHYSIOTHERAPY EQUIPMENT
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499672
Basic UDI-DI: 69560144PILCUK
Reference: 629967
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499665
Basic UDI-DI: 69560144PILCUK
Reference: 629966
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499658
Basic UDI-DI: 69560144PILCUK
Reference: 629965
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499641
Basic UDI-DI: 69560144PILCUK
Reference: 629964
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499634
Basic UDI-DI: 69560144PILCUK
Reference: 629963
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499627
Basic UDI-DI: 69560144PILCUK
Reference: 629962
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499610
Basic UDI-DI: 69560144PILCUK
Reference: 629961
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499603
Basic UDI-DI: 69560144PILCUK
Reference: 629960
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499597
Basic UDI-DI: 69560144PILCUK
Reference: 629959
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499580
Basic UDI-DI: 69560144PILCUK
Reference: 629958
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499573
Basic UDI-DI: 69560144PILCUK
Reference: 629957
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

Peripheral Intravascular Lithotripsy Catheter

Class IIbMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499566
Basic UDI-DI: 69560144PILCUK
Reference: 629956
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015

Class IIIMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499559
Basic UDI-DI: 69560144CILCRQ
Reference: 629955
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-CVIL-001 · Rev. A.4
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015

Class IIIMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499542
Basic UDI-DI: 69560144CILCRQ
Reference: 629954
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-CVIL-001 · Rev. A.4
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015

Class IIIMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499535
Basic UDI-DI: 69560144CILCRQ
Reference: 629953
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-CVIL-001 · Rev. A.4
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

CIVL25012, CIVL27512, CIVL30012, CIVL32512, CIVL35012, CIVL40012, CIVL25015, CIVL27515, CIVL30015, CIVL32515, CIVL35015, CIVL40015

Class IIIMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499528
Basic UDI-DI: 69560144CILCRQ
Reference: 629952
EMDN: C010401020101
EMDN description: PTCA BALLOON DILATION CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-CVIL-001 · Rev. A.4
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Double Lumen Catheter

Class IIIMDR 2017/745On the marketSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499511
Basic UDI-DI: 69560144DLCZM
Reference: 639951
EMDN: C0104010202
EMDN description: CARDIAC ANGIOGRAPHY GUIDE CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-DAMC-001 · Rev. 01
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Double Lumen Catheter

Class IIIMDR 2017/745On the marketSterile

Manufacturer: Shunmei Medical Co.,Ltd
Manufacturer SRN: CN-MF-000001160
UDI-DI: 06956014499504
Basic UDI-DI: 69560144DLCZM
Reference: 639950
EMDN: C0104010202
EMDN description: CARDIAC ANGIOGRAPHY GUIDE CATHETERS
First on market country: Türkiye
Safety summary (SSCP/SSP): SM-SSCP-DAMC-001 · Rev. 01
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details