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684 device results listed.

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Antigen Retrieval Solution

Acidity

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06977644783450
Basic UDI-DI: 6977644784980229B
Reference: 4980221
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent

90 mL/Vial

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

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070763237
Basic UDI-DI: 697507076000311RQ
Reference: 10301002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer I

1L/Bottle×6

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

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070763220
Basic UDI-DI: 697507076000310RN
Reference: 10201002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details

06974675460282

CLE-S1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675460282
Basic UDI-DI: 697467546802069N
Reference: C02001-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974675460268

DIL-S

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675460268
Basic UDI-DI: 697467546802019C
Reference: K02003-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974675460237

DIL-F

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675460237
Basic UDI-DI: 697467546803009F
Reference: C00001-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974675460183

CLE-F

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675460183
Basic UDI-DI: 6974675468010095
Reference: C00002-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:08

Manufacturer products Authorised representative products Authorised representative actors View details

06973356044780

Antibody Diluent

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagent

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: 06973356044780
Basic UDI-DI: 69733560410118R
Reference: AKBR1011050
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861105

Wash Buffer

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861105
Basic UDI-DI: 69732628600021ZE
Reference: 6012003
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861082

Sample Diluent

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861082
Basic UDI-DI: 69732628600020ZC
Reference: 6012303
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861068

Substrate

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861068
Basic UDI-DI: 69732628600019ZT
Reference: 01.09.40.10.01.07
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262861044

Substrate

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861044
Basic UDI-DI: 69732628600018ZR
Reference: 6012201
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973224898965

220 mL/bottle；220mLx2 bottles

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224898965
Basic UDI-DI: 6973224890072AK
Reference: DC10022
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890877

45 mL/bottle, 2 bottles/box

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890877
Basic UDI-DI: 6973224890047AL
Reference: DC10021
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890563

A-1: 5mL×2bottles; A-3: 45mL×2bottles; B-1: 5mL×2bottles; B-3: 45mL×2bottles; D-1: 5mL×2bottles; D-3: 120μL×100bottles; D-4: 45mL×2bottles; G-1: 5mL×2bottles; G-3: 45mL×2bottles; H-1: 5mL×2bottles; H-3: 45mL×2bottles

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890563
Basic UDI-DI: 6973224890043AC
Reference: DC10007
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890549

220mL×4bottles

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890549
Basic UDI-DI: 6973224890041A8
Reference: DC10002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224890518

Wash Buffer (10×) 1L×4bottles Wash Buffer (1×) 10L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224890518
Basic UDI-DI: 6973224890042AA
Reference: DC10004
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

Zybio

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236757
Basic UDI-DI: 69732628600120ZH
Reference: Sample Probe Cleaning Solution
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934958
Basic UDI-DI: 697122593GS58237DMT
Reference: NSDY110
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 B

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225934330
Basic UDI-DI: 697122593GS42693BLN
Reference: BL00230
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