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68 device results listed.

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Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

Model 6:Comprehensive inhalation group (inhalation group 1 + inhalation group 2 ) 25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454798
Basic UDI-DI: B-06976117454798
Reference: MY-0022-02
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

Model 5:Comprehensive food group (food group 1 + food group 2) 50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454781
Basic UDI-DI: B-06976117454781
Reference: MY-0025-02
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

Model 5:Comprehensive food group (food group 1 + food group 2) 25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454774
Basic UDI-DI: B-06976117454774
Reference: MY-0022-01
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:31

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630099

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630099
Basic UDI-DI: B-06976043630099
Reference: 009
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630082

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630082
Basic UDI-DI: B-06976043630082
Reference: 008
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630075

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630075
Basic UDI-DI: B-06976043630075
Reference: 007
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUCARE® Allergy THREE

AESKUCARE® Allergy

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510967
Basic UDI-DI: B-04250289510967
Reference: 820201
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

04049095010651

RIDA qLine® Allergy

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095010651
Basic UDI-DI: 4049095A6X4200000B2
Reference: A6142
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:49

Manufacturer products View details

PROTIA Allergy-Q 128M

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480658
Basic UDI-DI: 880944648ALM01HN
Reference: PALM0112
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q 64 Food Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480382
Basic UDI-DI: 880944648ALX02KF
Reference: PALX0212
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q 64 Inhalant Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480375
Basic UDI-DI: 880944648ALX01KD
Reference: PALX0112
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q Atopy Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480368
Basic UDI-DI: 880944648ALQ03JE
Reference: PALQ0312
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q Food Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480351
Basic UDI-DI: 880944648ALQ02JC
Reference: PALQ0212
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q Inhalant Panel

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480344
Basic UDI-DI: 880944648ALQ01JA
Reference: PALQ0112
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q 96M Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480269
Basic UDI-DI: 880944648ALT01JR
Reference: PALT0112
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

PROTIA Allergy-Q 64S Panel

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

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480108
Basic UDI-DI: 880944648ALX03KH
Reference: PALX0312
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Türkiye
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

ImmunoCAP ISAC E Detection Antibody

ImmunoCAP ISAC E112i

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021157
Basic UDI-DI: 7333066BUDI0036M3
Reference: 81-1022-01
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:35

Manufacturer products View details

ImmunoCAP ISAC E Control

ImmunoCAP ISAC E112i

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021140
Basic UDI-DI: 7333066BUDI0035LZ
Reference: 81-1021-01
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:35

Manufacturer products View details

ImmunoCAP ISAC E112i

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066021133
Basic UDI-DI: 7333066BUDI0034LX
Reference: 81-1020-01
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:35

Manufacturer products View details

Allergen-Specific IgE Antibody Kit（Fluorescence flow cytometry）

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301373
Basic UDI-DI: B-06941377301373
Reference: MY-0020-02
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 25.06.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details