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02.08.2026 22:01

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684 device results listed.

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Solution C

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934323
Basic UDI-DI: 697122593GS42693CLQ
Reference: CL00318
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Solution A

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934316
Basic UDI-DI: 697122593GS42693ALL
Reference: AL00118
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer H

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934309
Basic UDI-DI: 697122593GS42693HM2
Reference: ARHL001
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent1

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934286
Basic UDI-DI: 697122593GS58237AMM
Reference: DY05655
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Buffer Solution

Sheath-MF：20L

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454194
Basic UDI-DI: 697049309W0102000000399
Reference: MY-0009-03
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent

50 mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984065410
Basic UDI-DI: 69703416803205072JL
Reference: 0320509906
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

High-Voltage Adjustment Buffer

380 mL、1×2 L、1×1L

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062617
Basic UDI-DI: 69703416803205068JV
Reference: 679016
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Trigger Solution

640mL

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595763126
Basic UDI-DI: 6970291981002A2
Reference: CA1002P
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 11:14

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Release Reagent

AutoLumo analyzer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577178930
Basic UDI-DI: 697015090000360HH
Reference: CMT1403
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 11:12

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DETERGENT C

Please see UDI-DIs for details

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415903855
Basic UDI-DI: 69449040MYYQ-BM60******CL
Reference: 105-015410-00
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Enhanced Wash Buffer

10×52mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595778137
Basic UDI-DI: 693659579914QX
Reference: BF9914Q
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Enhanced Wash Buffer

3×600T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595775952
Basic UDI-DI: 693659571007MV
Reference: CF1007P
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Enhanced Wash Buffer

100mL(2×50mL)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595773866
Basic UDI-DI: 693659571004MP
Reference: CF1004P
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent (CLIA)

50mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595773859
Basic UDI-DI: 693659571005MR
Reference: CF1005P
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 10:09

Manufacturer products Authorised representative products Authorised representative actors View details

DELFIA Inducer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147299645
Basic UDI-DI: 6438147GSP_InducerLH
Reference: 3304-0010
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

GSP Wash Concentrate

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147300051
Basic UDI-DI: 6438147GSP_WashConcZW
Reference: 4080-0010
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

DELFIA Inducer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147267521
Basic UDI-DI: 6438147DX_InducerRT
Reference: 3027-0010
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

DELFIA Diluent 3

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147244881
Basic UDI-DI: 6438147D/AD_Diluent33B
Reference: 4021-0010
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

DELFIA Wash Concentrate

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147178162
Basic UDI-DI: 6438147DX_WashConcZ4
Reference: 3014-0010
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

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DELFIA Diluent II

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147009763
Basic UDI-DI: 6438147D/AD/DX_Diluent2RA
Reference: B131-100
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details