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Access HBs Ab Calibrators

IVD Annex II List ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24297UC
Basic UDI-DI: B-A24297UC
EMDN: W0102152299
Market status: Not specified
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 23.05.2026 11:01

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Access HBs Ag Calibrators

IVD Annex II List ANot specifiedOn the market

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24292U2
Basic UDI-DI: B-A24292U2
EMDN: W0102152299
Market status: Not specified
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 23.05.2026 11:01

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ClinCal® Urine Calibrator, lyophil., for Phenolic Compounds

IVD generalNot specifiedOn the market

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9925CT
Basic UDI-DI: B-9925CT
EMDN: W0101050301
Market status: Not specified
Authorised representative: -
Last updated: 23.05.2026 11:01

Manufacturer products View details

ClinCal® Urine Calibrator, lyophil., for Occupational Medicine

IVD generalNot specifiedOn the market

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9922CM
Basic UDI-DI: B-9922CM
EMDN: W0101050301
Market status: Not specified
Authorised representative: -
Last updated: 23.05.2026 11:01

Manufacturer products View details

ClinCal® Serum Calibrator Set, lyophil., for Amiodarone and Desethylamiodarone (Level 0 - 3)

IVD generalNot specifiedOn the market

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9909CV
Basic UDI-DI: B-9909CV
EMDN: W0101050301
Market status: Not specified
Authorised representative: -
Last updated: 23.05.2026 11:01

Manufacturer products View details

BM Test HbA1c Calibrator

IVD generalNot specifiedOn the market

Manufacturer: JEOL Ltd. MF
Manufacturer SRN: JP-MF-000026608
UDI-DI: D-780609981T6
Basic UDI-DI: B-780609981T6
EMDN: W01010214
Market status: Not specified
Authorised representative: JEOL(Europe)BV AR
Last updated: 23.05.2026 11:01

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SPOTCHEM D Calibrator Kit

IVD generalNot specifiedNo longer on the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77964KK
Basic UDI-DI: B-77964KK
EMDN: W0101050301
Market status: Not specified
Authorised representative: ARKRAY Europe, B.V.
Last updated: 23.05.2026 11:01

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SPOTCHEM CALIBRATOR KIT

IVD generalNot specifiedOn the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-77041IS6
Basic UDI-DI: B-77041IS6
EMDN: W0101050301
Market status: Not specified
Authorised representative: ARKRAY Europe, B.V.
Last updated: 23.05.2026 11:01

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Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991703QP
Basic UDI-DI: B-693757991703QP
EMDN: W0105090401
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991702QM
Basic UDI-DI: B-693757991702QM
EMDN: W0105090401
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991701QK
Basic UDI-DI: B-693757991701QK
EMDN: W0105090401
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Diagnostic Kit for Helicobacter pylori antigen (Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757991602QG
Basic UDI-DI: B-693757991602QG
EMDN: W0105010401
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Diagnostic kit for anti-HAV IgM( Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990612QC
Basic UDI-DI: B-693757990612QC
EMDN: W0105020104
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Diagnostic kit for Antibody to Treponema Pallidum (Colloidal Gold)

IVD generalNot specifiedNo longer on the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990609QP
Basic UDI-DI: B-693757990609QP
EMDN: W0105010302
Market status: Not specified
Authorised representative: SUNGO Europe B.V.
Last updated: 23.05.2026 10:51

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Fast Diagnostic Screening Test for Sperm Concentration

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990302PS
Basic UDI-DI: B-693757990302PS
EMDN: W0102109013
Market status: Not specified
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.05.2026 10:51

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DIAGNOSTIC SETS OTOSCOPE SET

Class INot specifiedOn the market

Manufacturer: Daddy D Pro
Manufacturer SRN: PK-MF-000035172
UDI-DI: B961DP78602130
Basic UDI-DI: B-B961DP78602130
EMDN: Q010399
Market status: Not specified
Authorised representative: ANTEX MEDI SOLUTION
Last updated: 23.05.2026 10:51

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DIAGNOSTIC SETS COMBINATION SET

Class INot specifiedOn the market

Manufacturer: Daddy D Pro
Manufacturer SRN: PK-MF-000035172
UDI-DI: B961DP78602120
Basic UDI-DI: B-B961DP78602120
EMDN: Q010399
Market status: Not specified
Authorised representative: ANTEX MEDI SOLUTION
Last updated: 23.05.2026 10:51

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Gold Standard Diagnostics RPR Reagent Pack

IVD generalNot specifiedOn the market

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD341600R0
Basic UDI-DI: B-B350GSD341600R0
EMDN: W0105010399
Market status: Not specified
Authorised representative: Emergo Europe B.V.
Last updated: 23.05.2026 10:51

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Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C

IVD generalNot specifiedOn the market

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD0116005C0
Basic UDI-DI: B-B350GSD0116005C0
EMDN: W0105010399
Market status: Not specified
Authorised representative: Emergo Europe B.V.
Last updated: 23.05.2026 10:51

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Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System

IVD generalNot specifiedOn the market

Manufacturer: Gold Standard Diagnostics, LLC
Manufacturer SRN: US-MF-000027142
UDI-DI: B350GSD0116000
Basic UDI-DI: B-B350GSD0116000
EMDN: W0105010399
Market status: Not specified
Authorised representative: Emergo Europe B.V.
Last updated: 23.05.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details