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Heparin Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603857
Basic UDI-DI: B-06926802603857
Reference: MCT00301E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Functional Fibrinogen Assay

Functional Fibrinogen Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603802
Basic UDI-DI: B-06926802603802
Reference: MCT00601E
EMDN: W0103020201
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603604
Basic UDI-DI: B-06926802603604
Reference: MCL00901E
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603574
Basic UDI-DI: B-06926802603574
Reference: MCL01001E
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiopulmonary Markers Controls

Cardiopulmonary Markers Controls

IVD generalIVDDOn the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603413
Basic UDI-DI: B-06926802603413
Reference: MCL01101E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP08-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000949
Basic UDI-DI: B-06926724000949
Reference: TJEP08-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP07-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000932
Basic UDI-DI: B-06926724000932
Reference: TJEP07-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP06-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000925
Basic UDI-DI: B-06926724000925
Reference: TJEP06-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP05-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000918
Basic UDI-DI: B-06926724000918
Reference: TJEP05-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP04-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000901
Basic UDI-DI: B-06926724000901
Reference: TJEP04-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP03-320

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000895
Basic UDI-DI: B-06926724000895
Reference: TJEP03-320
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP08-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000888
Basic UDI-DI: B-06926724000888
Reference: TJEP08-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP07-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000871
Basic UDI-DI: B-06926724000871
Reference: TJEP07-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP06-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000864
Basic UDI-DI: B-06926724000864
Reference: TJEP06-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP05-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000857
Basic UDI-DI: B-06926724000857
Reference: TJEP05-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP04-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000840
Basic UDI-DI: B-06926724000840
Reference: TJEP04-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

TJEP03-190

Class IIIMDDOn the marketSingle useSterile

Manufacturer: Beijing Taijieweiye Technology Co., Ltd.
Manufacturer SRN: CN-MF-000004540
UDI-DI: 06926724000833
Basic UDI-DI: B-06926724000833
Reference: TJEP03-190
EMDN: C01050202
EMDN description: PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS
First on market country: Poland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Acetabular Liner

Class IIIMDDOn the marketImplantableSingle useSterile

Manufacturer: Tianjin Zhengtian Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000020115
UDI-DI: 06926705862344
Basic UDI-DI: B-06926705862344
Reference: P28012840
EMDN: P090803040101
EMDN description: STANDARD POLYETHYLENE HIP PROSTHESES INSERTS
First on market country: Portugal
Authorised representative: Inion Oy
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trial 12mm 12°

E06-R-1100-09

Class IMDDOn the marketReusable

Manufacturer: Shanghai REACH Medical Instrument Co., Ltd
Manufacturer SRN: CN-MF-000010269
UDI-DI: 06926555494924
Basic UDI-DI: B-06926555494924
Reference: E06-R-1100-09
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Trial 15mm 15°

E06-R-1100-15

Class IMDDOn the marketReusable

Manufacturer: Shanghai REACH Medical Instrument Co., Ltd
Manufacturer SRN: CN-MF-000010269
UDI-DI: 06926555494948
Basic UDI-DI: B-06926555494948
Reference: E06-R-1100-15
EMDN: L0999
EMDN description: ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details