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Anti-CL IgA CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547161
Basic UDI-DI: 697015090000330H8
Reference: CMQ3703
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:20

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Anti-CL IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547062
Basic UDI-DI: 697015090000329HP
Reference: CMQ3603
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anti-CL IgG CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546980
Basic UDI-DI: 697015090000328HM
Reference: CMQ3505
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anti-CL CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546881
Basic UDI-DI: 697015090000327HK
Reference: CMQ3405
EMDN: W0102100501
EMDN description: ANTI-CARDIOLIPIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anti-β2-GP1 IgM CLIA Microparticles

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IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546782
Basic UDI-DI: 697015090000324HD
Reference: CMQ3205
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anti-β2-GP1 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359546683
Basic UDI-DI: 697015090000323HB
Reference: CMQ3105
EMDN: W0102100503
EMDN description: ANTI-B2-GLYCOPROTEIN I ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anti-CCP IgG CLIA Microparticles

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543989
Basic UDI-DI: 697015090000116H4
Reference: CMQ1405
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Aerobic Culture Bottle FA Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System.

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525817
Basic UDI-DI: 697015090000150H4
Reference: MC0311
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Anaerobic Culture Bottle FN Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525831
Basic UDI-DI: 697015090000152H8
Reference: MC0315
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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Aerobic Culture Bottle PF Plus

Automated Blood Culture system, Microbial Detection System and Automated Microbial Detection System

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525824
Basic UDI-DI: 697015090000151H6
Reference: MC0313
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 05.08.2026 16:19

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G22-Absorbent Paper Points-GAPA-ISO #60

Gutta Percha Points

Class IIaMDR 2017/745On the marketDirect markingImplantableSingle use

Manufacturer: TIANJIN GAPADENT CO., LTD
Manufacturer SRN: CN-MF-000030044
UDI-DI: 06941974304104
Basic UDI-DI: 697015700GAPAGPBY
Reference: 06941974304104
EMDN: Q01010401
EMDN description: PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

MEDICAL GLOVES

Class IMDR 2017/745On the marketSingle use

Manufacturer: FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
Manufacturer SRN: CN-MF-000009645
UDI-DI: 06942272603524
Basic UDI-DI: 69422726P4.04.01Y2
Reference: FS-352 S
EMDN: T01020201
EMDN description: VINYL EXAMINATION / TREATMENT GLOVES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Stage Balloon Dilatation Catheter

Multi-Stage Balloon Dilatation Catheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000012832
UDI-DI: 06942127892639
Basic UDI-DI: 697067138MS055J4
Reference: AF-D0618TBC10/11/1230F
EMDN: G03010199
EMDN description: GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Reusable, Stainless Steel, Non-Sterile, Forceps

Class IMDR 2017/745On the marketReusable

Manufacturer: Shandong Weigao Orthopaedic Device Company Limited.
Manufacturer SRN: CN-MF-000019785
UDI-DI: 06942082351202
Basic UDI-DI: 6903095SFOR05YY
Reference: 20505404
EMDN: L091301
EMDN description: BONE GRASPS, REUSABLE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:19

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Brokeback Device (Ⅴ)

Spinal Fixation Surgical Instrument

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Beijing Fule Science & Technology Development Co., Ltd.
Manufacturer SRN: CN-MF-000006511
UDI-DI: 06942072973827
Basic UDI-DI: 69420729SFSI02S6
Reference: 1906147
EMDN: L090901
EMDN description: BONE CUTTERS, REUSABLE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Non-sterile X-ray Detectable Gauze Swabs 不灭菌带X线纱布片

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 06942013216228
Basic UDI-DI: 697023378GauzeSwabsNStNC
Reference: AG17150812X-10T
EMDN: M0201020202
EMDN description: COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILE
First on market country: Slovenia
Authorised representative: RAFFIN MEDICAL
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable vinyl examination gloves

S、M、L

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 06942013206663
Basic UDI-DI: 697023378Glove2D
Reference: 206001 for Reflex
EMDN: T01020201
EMDN description: VINYL EXAMINATION / TREATMENT GLOVES
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

First Aid Dressing Bandage

6*300cm，8*400cm，10*400cm，12*500cm，10*12cm、10*10cm、6*8cm

Class IMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 06942013206045
Basic UDI-DI: 697023378stBandagesL4
Reference: 2020000135 for Reflex
EMDN: M03030199
EMDN description: ELASTIC FIXING BANDAGES - OTHER
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sterile Gauze Swabs

5*5cm、7.5*7.5cm、8*10cm、10*10cm、15*15cm、10*20cm

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Hubei V-Medical Products Co.,Ltd.
Manufacturer SRN: CN-MF-000011268
UDI-DI: 06942013203136
Basic UDI-DI: 697023378stgauzeSwabs9G
Reference: BSG1715081210-T
EMDN: M0299
EMDN description: GAUZES - OTHER
First on market country: France
Authorised representative: RAFFIN MEDICAL
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

Orthodontic Elastics

Orthodontic Elastics

Class IIaMDR 2017/745On the marketSingle use

Manufacturer: Hangzhou DTC Medical Apparatus Co.,Ltd
Manufacturer SRN: CN-MF-000032021
UDI-DI: 06941985550118
Basic UDI-DI: 69419855DTCTL100016Q
Reference: VI85504
EMDN: Q010404
EMDN description: ORTHODONTIC ELASTICS, CHAINS AND SPRINGS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details