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IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155820
Basic UDI-DI: 8058945155N30033A
Reference: 5N3003
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:16

Manufacturer products View details

CHORUS EVO SANITIZING SOLUTION

EVOSANITSOL

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322823
Basic UDI-DI: 803389132EVOSANITSOL00US
Reference: 82052
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:19

Manufacturer products View details

CHORUS EVO DECONTAMINATION BUFFER

EVODECONTBUFR

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891322816
Basic UDI-DI: 803389132EVODECONTBUFR0NU
Reference: 82050
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:18

Manufacturer products View details

MYTHIC 3CRP CRP-L

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Orphée SA
Manufacturer SRN: CH-MF-000050926
UDI-DI: 07640142480235
Basic UDI-DI: 764014248HM3CRP-005LWT
Reference: HM3CRP-005-L0040
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Poland
Authorised representative: PZ CORMAY Spółka Akcyjna
Last updated: 03.07.2026 06:31

Manufacturer products Authorised representative products Authorised representative actors View details

EasySep™ Buffer

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: STEMCELL Technologies Canada Inc
Manufacturer SRN: CA-MF-000031794
UDI-DI: 07540207107803
Basic UDI-DI: 7540207EASYSEP0003DN
Reference: 100-0780
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: STEMCELL Technologies Canada Inc
Manufacturer SRN: CA-MF-000031794
UDI-DI: 07540207107490
Basic UDI-DI: 7540207EASYSEP0002DL
Reference: 100-0749
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

ImmunoCAP ISAC Starter Pack

ImmunoCAP ISAC E112i

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021119
Basic UDI-DI: 7333066BUDI0032LT
Reference: 81-1010-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

Washing Solution

System reagents

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019505
Basic UDI-DI: 7333066BUDI0001LG
Reference: 10-9202-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

ImmunoCAP Rapid Developer Solution Pipette

ImmunoCAP Rapid

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066017655
Basic UDI-DI: 7333066BUDI0039M9
Reference: 82-1004-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

ImmunoCAP Rapid Developer Solution

ImmunoCAP Rapid

IVD Class AIVDR 2017/746On the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066017686
Basic UDI-DI: 7333066BUDI0041LU
Reference: 82-1030-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

EliA Dummy Well

System Accessories

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014616
Basic UDI-DI: 7333066BUDI0026LY
Reference: 14-5510-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

ImmunoCAP Specific IgA/IgG Sample Diluent

Sample Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066011677
Basic UDI-DI: 7333066BUDI0040LS
Reference: 10-9361-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP IgE/ECP/Tryptase Sample Diluent

Sample Diluent

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066011660
Basic UDI-DI: 7333066BUDI0003LL
Reference: 10-9360-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

Development Solution

System reagents

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066011097
Basic UDI-DI: 7333066BUDI0007LU
Reference: 10-9439-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Dummy ImmunoCAP

System Accessories

IVD Class AIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003023
Basic UDI-DI: 7333066BUDI0023LS
Reference: 14-4317-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

Dilution Plate, Phadia 250

System Accessories

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066001036
Basic UDI-DI: 7333066BUDI0014LR
Reference: 12-3907-08
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:14

Manufacturer products View details

Wash Solution

WS II

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06977644786796
Basic UDI-DI: 6977644784980429H
Reference: 4980421
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cleaning Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06977644783481
Basic UDI-DI: 6977644784081216B
Reference: 4081211
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Solution

WS I

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06977644783474
Basic UDI-DI: 6977644784980419F
Reference: 4980411
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

Antigen Retrieval Solution

Alkalinity

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Dakewe Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000002174
UDI-DI: 06977644783467
Basic UDI-DI: 69776447849802199
Reference: 4980211
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