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SURGEON

Surgical Blades (Sterile & Non-sterile) / Scalpel Blade

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Jai Surgicals Limited
Manufacturer SRN: IN-MF-000012813
UDI-DI: 18902828033484
Basic UDI-DI: 8902828SBXC
Reference: 03348
EMDN: V010302
EMDN description: BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:56

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SURGEON

Disposable scalpels including safety type (Sterile Scalpel & Non-sterile Scalpel)

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Jai Surgicals Limited
Manufacturer SRN: IN-MF-000012813
UDI-DI: 18902828019105
Basic UDI-DI: 8902828DSWZ
Reference: 01910
EMDN: V010101
EMDN description: SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:56

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SURGEON

Stitch Cutters (Sterile)

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Jai Surgicals Limited
Manufacturer SRN: IN-MF-000012813
UDI-DI: 18902828003296
Basic UDI-DI: 8902828SCXE
Reference: 00329
EMDN: V0199
EMDN description: CUTTING DEVICES, SINGLE-USE - OTHER
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 16.07.2026 12:56

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KIATO PLUS

Surgical Blades (Sterile) in Carbon Steel & Stainless Steel with or without Twin Rib

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Aditya Dispomed Products Pvt. Ltd.
Manufacturer SRN: IN-MF-000020014
UDI-DI: 08902895180107
Basic UDI-DI: 8902895ADPTF01SURBLDG5
Reference: 18010
EMDN: V010302
EMDN description: BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 12:51

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Disposable razor

TPS DE01

Class IMDR 2017/745On the marketSingle use

Manufacturer: HANGZHOU TUOPUSI MEDICAL PRODUCTS CO.,LTD
Manufacturer SRN: CN-MF-000039733
UDI-DI: 06977143461767
Basic UDI-DI: 697714346TPSDE017H
Reference: TPS DE01
EMDN: V010102
EMDN description: SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 16.07.2026 11:21

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Sterile Surgical Blades

No.10

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Suzhou Kyuan Medical Apparatus Co., Ltd
Manufacturer SRN: CN-MF-000021229
UDI-DI: 26971517660576
Basic UDI-DI: 697151766SurgicalbladecXW
Reference: No.15
EMDN: V010302
EMDN description: BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES
First on market country: Italy
Authorised representative: Llins Service & Consulting GmbH
Last updated: 16.07.2026 11:04

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Scissors

Stainless steel、Cold rolled steel+nickel plating、Stainless steel and plastic handle

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 16970233787768
Basic UDI-DI: 697023378Scissors4K
Reference: 370153
EMDN: V0199
EMDN description: CUTTING DEVICES, SINGLE-USE - OTHER
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 16.07.2026 10:54

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06957138617027

XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVIII, XXX, XXXIV, XXXVI

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Tianjin Huahong Technology Co., Ltd.
Manufacturer SRN: CN-MF-000015849
UDI-DI: 06957138617027
Basic UDI-DI: 69571386SL02WU
Reference: No
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:51

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blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571828
Basic UDI-DI: 69507155KKIT5SB
Reference: KF-B12
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Spain
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571804
Basic UDI-DI: 69507155KKIT3S7
Reference: KF-B12
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Spain
Safety summary (SSCP/SSP): 1R2301-YF3-DHF-CE-050 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571798
Basic UDI-DI: 69507155CKIT5PK
Reference: CGH10
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Spain
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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blood glucose monitoring system

Blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715571781
Basic UDI-DI: 69507155CKIT3PF
Reference: CGH10
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Spain
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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

blood glucose monitoring system

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitMicrobial substancesNear-patient testingReagentSelf testing

Manufacturer: Cofoe Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000001077
UDI-DI: 06950715563076
Basic UDI-DI: 69507155CKIT4PH
Reference: CGH11
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Germany
Safety summary (SSCP/SSP): 1N2124-YF3-DHF-CE-088 · Rev. A4
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 10:48

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Sinocare

Disposable Blood Lancets

Class IIaMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630144711
Basic UDI-DI: 6945630101B9
Reference: Soft 28G
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

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CHIMTEX LTD

Disposable Steel Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630144650
Basic UDI-DI: 6945630150BN
Reference: "Steel 50-0101"
EMDN: V010402
EMDN description: LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Bulgaria
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

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Securlancets

Disposable Safety Lancets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 16945630116800
Basic UDI-DI: 6945630105BH
Reference: 49956 Flex3 28G
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:44

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06941558063885

Sterile Scalpel

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Allmed Medical Products Co.,Ltd
Manufacturer SRN: CN-MF-000007970
UDI-DI: 06941558063885
Basic UDI-DI: 69415580scalpelGG
Reference: AMCUTA0001
EMDN: V010102
EMDN description: SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:38

Manufacturer products Authorised representative products Authorised representative actors View details

TRI Sicherheitslanzette

XA1, XA2, XA3, XA4, XA5, XA6, XA1 Pro, XA3 Pro, XA5 Pro, XA11 Pro

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Ningbo Medsun Medical Co., Ltd.
Manufacturer SRN: CN-MF-000011842
UDI-DI: 06934047905995
Basic UDI-DI: 69340479EU01XALQ
Reference: 13100861
EMDN: V010401
EMDN description: LANCETS WITH SAFETY SYSTEMS, SINGLE-USE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:30

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Swann-Morton Limited

36 / P6 / 39 /49 Codes

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Swann-Morton Ltd
Manufacturer SRN: GB-MF-000001890
UDI-DI: 05033955039059
Basic UDI-DI: 50339550STERILEEORET8S
Reference: 3905 - No. 15 Sterile Retractable Scalpels
EMDN: V010102
EMDN description: SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:45

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Swann-Morton Limited

23 / 40 / 35 / LC / NU / PC Codes

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Swann-Morton Ltd
Manufacturer SRN: GB-MF-000001890
UDI-DI: 05033955023393
Basic UDI-DI: 50339550NONSTDISPSH9
Reference: 2339 - No. 24 Bulk Non Sterile Disposable Scalpels with Guard
EMDN: V010102
EMDN description: SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:45

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