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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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IVD Class AIVDR 2017/746On the marketKitReagentSingle use

Manufacturer: Shenzhen Hailife Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042748
UDI-DI: 06977254770031
Basic UDI-DI: 697725477R1003H8
Reference: R100302EN
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer

iMC Ge52e

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Changsha Han Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000042919
UDI-DI: 06977216100418
Basic UDI-DI: 697721610020010002DR
Reference: 041
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

CD20 Antibody Reagent (Immunohistochemistry)

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Beijing Biosynthesis Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040500
UDI-DI: 06977075597053
Basic UDI-DI: 697707559BH0705CGR
Reference: 705
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

Vimentin Antibody Reagent (Immunohistochemistry)

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Beijing Biosynthesis Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040500
UDI-DI: 06977075597046
Basic UDI-DI: 697707559BH0704CGN
Reference: 704
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:09

Manufacturer products Authorised representative products Authorised representative actors View details

P-53 Tumor Suppressor Protein Antibody Reagent (Immunohistochemistry)

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Beijing Biosynthesis Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040500
UDI-DI: 06977075597039
Basic UDI-DI: 697707559BH0703CGK
Reference: 703
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Mucin 2 Antibody Reagents (Immunohistochemistry)

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Beijing Biosynthesis Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040500
UDI-DI: 06977075597022
Basic UDI-DI: 697707559BH0702CGG
Reference: 702
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 14 Antibody Reagents (Immunohistochemistry)

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagent

Manufacturer: Beijing Biosynthesis Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040500
UDI-DI: 06977075597015
Basic UDI-DI: 697707559BH0701CGD
Reference: 701
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence & Bright-Field Multifunctional Digital Pathology Scanner

KR-MD9-PLUS

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Jiangsu KR Pharmetech Co., Ltd.
Manufacturer SRN: CN-MF-000051331
UDI-DI: 06976873690010
Basic UDI-DI: 697687369MD9Z4
Reference: 06976873690010
EMDN: W02079099
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

Sterile Tube Welder

Class IMDR 2017/745On the marketActive device

Manufacturer: Wuhan bms Medicaltech Co.,Ltd.
Manufacturer SRN: CN-MF-000037241
UDI-DI: 06976052440092
Basic UDI-DI: 697605244030496
Reference: 0304
EMDN: V9099
EMDN description: VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

Magnetic Rod Sleeve

Magnetic Rod Sleeve

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360273
Basic UDI-DI: 697557836030020002Z6
Reference: 3060340
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Tip

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360266
Basic UDI-DI: 697557836030020001Z4
Reference: 3060283
EMDN: W0503020202
EMDN description: PIPETTES, TIPS WITHOUT FILTER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction or Purification Reagent

TF1

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360112
Basic UDI-DI: 697557836010040003YQ
Reference: 8203001
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction or Purification Reagent

CF1

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360105
Basic UDI-DI: 697557836010040001YL
Reference: 2000259
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Detection Reaction Construction System

AP10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360020
Basic UDI-DI: 697557836020020001YH
Reference: 1000042
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Digital PCR System

AD3207

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360037
Basic UDI-DI: 697557836020010001Y6
Reference: 1200889
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Microfluidic Chip

V3.0

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360006
Basic UDI-DI: 697557836030010002YT
Reference: 3100053
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction or Purification Reagent

Easy-CF2

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360013
Basic UDI-DI: 697557836010040002YN
Reference: 2000241
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Collection Tube

No Additive, Plain Tube, Clot Activator, Gel & Clot Activator, EDTA K2, EDTA K3, EDTA & Gel, Sodium Citrate 9NC, ESR 4NC, Sodium Citrate & Gel, NaF & EDTA, Lithium Heparin, Sodium Heparin, Lithium Heparin & Gel, Sodium Heparin & Gel, ACD, ACD & Gel

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Changsha Renji Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000030318
UDI-DI: 06975473970829
Basic UDI-DI: 697547397030010001YC
Reference: 030010001
EMDN: W050101010202
EMDN description: BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR
First on market country: Malta
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:06

Manufacturer products Authorised representative products Authorised representative actors View details

Underpad

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: ZHEJIANG NEW VISION IMP & EXP CO.,LTD
Manufacturer SRN: CN-MF-000029312
UDI-DI: 06974415280378
Basic UDI-DI: 697441528Upad0000108766Z
Reference: 4060
EMDN: T04010299
EMDN description: ABSORBENT UNDERPADS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:58

Manufacturer products Authorised representative products Authorised representative actors View details

Pangaea Super 8 Pro Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860143
Basic UDI-DI: 69741498614YV
Reference: H622202
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details