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ImmunoCAP Allergen rx1, Regional

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066008110
Basic UDI-DI: 7333066BUDI0017LX
Reference: 14-5193-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

ImmunoCAP Allergen rx3, Regional

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066008219
Basic UDI-DI: 7333066BUDI0017LX
Reference: 14-5198-01
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: -
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-020853-00、105-002240-00、105-002241-00、105-020854-00、105-004501-00、105-004502-00、105-002309-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986827
Basic UDI-DI: 69449040004JIgE********W8
Reference: 105-020853-00
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.08.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986841
Basic UDI-DI: 69449040004JIgE********W8
Reference: 105-020854-00
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 12.08.2026 00:10

Manufacturer products Authorised representative products Authorised representative actors View details

Dust Mite IgE Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ODME-R4029Q
Basic UDI-DI: B-ODME-R4029Q
Reference: ODME-R402
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.08.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 rApi m 1 Specific Allergen

IVDR_67_LLB_DUB-C_B_REAG_rApi m 1 Specific Allergen

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414594002
Basic UDI-DI: 0405686900607VF
Reference: 10368595
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 nPru p 3 Specific Allergen

IVDR_67_LLB_DUB-C_B_REAG_nPru p 3 Specific Allergen

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414006284
Basic UDI-DI: 0405686900544VG
Reference: 10368596
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Dill Specific Allergen

IVDR_67_LLB_DUB-C_A_REAG_Dill Specific Allergen

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414972497
Basic UDI-DI: 0405686900219V2
Reference: 10385767
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 European Hornet Specific Allergen

IVDR_67_LLB_DUB-C_B_REAG_European Hornet Spfc Algn

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414996059
Basic UDI-DI: 0405686900386VN
Reference: 10385964
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 rApi m 2 Specific Allergen

IVDR_67_LLB_DUB-C_B_REAG_rApi m 2 Specific Allergen

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414594019
Basic UDI-DI: 0405686900608VH
Reference: 10713569
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 rVes v 5 Specific Allergen

IVDR_67_LLB_DUB-C_B_REAG_rVes v 5 Specific Allergen

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414594026
Basic UDI-DI: 0405686900632VE
Reference: 10713576
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

DS-EIA-IgE TOTAL

IVD generalNot specifiedNo longer on the market

Manufacturer: RPC Diagnostic Systems Ltd.
Manufacturer SRN: RU-MF-000043555
UDI-DI: 04605979402181
Basic UDI-DI: B-04605979402181
Reference: ET-151/1.1
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: -
Authorised representative: AB Diagnostic Systems GmbH
Last updated: 07.08.2026 16:48

Manufacturer products Authorised representative products Authorised representative actors View details

04260153755400

Allergen Discs Zimt

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153755400
Basic UDI-DI: B-04260153755400
Reference: 37119008
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

04260153755073

Allergen Discs Fusarium culmorum

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153755073
Basic UDI-DI: B-04260153755073
Reference: 37113018
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

04260153755066

Allergen Discs Curvularia lunata

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153755066
Basic UDI-DI: B-04260153755066
Reference: 37113016
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

04260153752638

Allergen Discs Guarkernmehl

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153752638
Basic UDI-DI: B-04260153752638
Reference: 37106053
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

04260153752300

Allergen Discs Haselnuss

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153752300
Basic UDI-DI: B-04260153752300
Reference: 37106017
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

04260153752294

Allergen Discs Walnuss

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: 04260153752294
Basic UDI-DI: B-04260153752294
Reference: 37106016
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:17

Manufacturer products View details

Panel 30 PEDI_A

AllergyScreen®/AlleisaScreen®

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik
Manufacturer SRN: DE-MF-000004992
UDI-DI: 04251342603701
Basic UDI-DI: B-04251342603701
Reference: 0370
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:14

Manufacturer products View details

Panel 30 Pedi K

AllergyScreen®/AlleisaScreen®

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik
Manufacturer SRN: DE-MF-000004992
UDI-DI: 04251342603374
Basic UDI-DI: B-04251342603374
Reference: 0337
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:14

Manufacturer products View details