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Calibrator for use with AUTOF MS

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908256
Basic UDI-DI: B-06970150908256
Reference: MSA02
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cholylglycine CLIA Microparticles

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908126
Basic UDI-DI: B-06970150908126
Reference: CMM0502
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

uE3 CLIA Microparticals

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359505871
Basic UDI-DI: B-06942359505871
Reference: CMN0401
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo

Wondfo One Step HIV1/2 Whole Blood/Serum/Plasma Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289817905
Basic UDI-DI: B-06933289817905
Reference: W752-C4G3-E
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:25

Manufacturer products Authorised representative products Authorised representative actors View details

76499888085248

Nucleic Acid Extraction Kit - Pack of 5

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

Manufacturer: Testmate Health SA
Manufacturer SRN: CH-MF-000056839
UDI-DI: 76499888085248
Basic UDI-DI: 7649988808506001306LN
Reference: 06-001-306
EMDN: W05010299
EMDN description: URINE COLLECTION DEVICES - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 11:45

Manufacturer products Authorised representative products Authorised representative actors View details

NGS Universal Index Kit (Illumina)

24 indexes、96 indexes/plate

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Xukang Medical Technology (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000017865
UDI-DI: 06974679040626
Basic UDI-DI: 697467904XKUDI0018AB
Reference: YK009-004-CE
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 11:13

Manufacturer products Authorised representative products Authorised representative actors View details

Gram Negative bacteria AST (MALDI-TOF MS)

Automated Mass Spectrometry Microbial Identification System

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359511209
Basic UDI-DI: 697015090000367HX
Reference: MS0301
EMDN: W0104080109
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Gram Positive bacteria AST (MALDI-TOF MS)

Automated Mass Spectrometry Microbial Identification System（Autof）

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359511179
Basic UDI-DI: 697015090000366HV
Reference: MS0201
EMDN: W0104080110
EMDN description: COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM POSITIVES - AUTOMATED
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem TP

Automatic Chemistry Analyzer

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253000120
Basic UDI-DI: 69422530000002N2
Reference: 360101TP0000S
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Glycohemoglobin Analyzer

P10, P60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289831673
Basic UDI-DI: 69332898CE5100F8
Reference: WK02
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:29

Manufacturer products Authorised representative products Authorised representative actors View details

06933289816809

2019-nCoV Antigen Test (Lateral Flow Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816809
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0024
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: France
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:29

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

06933289816816

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816816
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0025
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:58

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

06933289816823

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289816823
Basic UDI-DI: 69332898CE1606FH
Reference: W634P0026
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CSD-W634(2)-01-06 · Rev. 04
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:58

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

Automatic Glycohemoglobin Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289857338
Basic UDI-DI: 69332898CE5100F8
Reference: WK37
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:58

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470184

Inuvi-005/CE Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470184
Basic UDI-DI: 5061107470184RR
Reference: Inuvi-005/CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470177

Inuvi-004/CE Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470177
Basic UDI-DI: 5061107470177RU
Reference: Inuvi-004/CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470160

Inuvi-003/CE Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470160
Basic UDI-DI: 5061107470160RB
Reference: Inuvi-003/CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

05061107470153

Inuvi-001/CE Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitSingle use

Manufacturer: Inuvi Health Limited
Manufacturer SRN: UK-MF-000057167
UDI-DI: 05061107470153
Basic UDI-DI: 5061107470153RE
Reference: Inuvi-001/CE
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

FIX&PERM® Cell Fixation and Permeabilization kit

FIX&PERM®

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Vector Laboratories, Inc.
Manufacturer SRN: US-MF-000057003
UDI-DI: 00860015684509
Basic UDI-DI: 08600156845FIXPERMCEIVDRQ
Reference: GAS-002-CE/IVD
EMDN: W0103080599
EMDN description: AUXILIARY & SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:58

Manufacturer products Authorised representative products Authorised representative actors View details

Embryo Predict

200-00201

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Alife Health Inc.
Manufacturer SRN: US-MF-000028240
UDI-DI: 00860008987204
Basic UDI-DI: 08600089872HERARB
Reference: 200-00201
EMDN: Z12080292
EMDN description: GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details