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170 device results listed.

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D-EIM4281053HA

FT3 Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281053HA
Basic UDI-DI: B-EIM4281053HA
Reference: EIM4281053
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281052H8

T4 Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281052H8
Basic UDI-DI: B-EIM4281052H8
Reference: EIM4281052
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281051H6

T3 Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281051H6
Basic UDI-DI: B-EIM4281051H6
Reference: EIM4281051
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01833037W

C-reactive protein (CRP) Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01833037W
Basic UDI-DI: B-ECH01833037W
Reference: ECH0183303
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01833017S

Anti-Streptolysin O (ASO) Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01833017S
Basic UDI-DI: B-ECH01833017S
Reference: ECH0183301
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01823037P

C-reactive protein (CRP) Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01823037P
Basic UDI-DI: B-ECH01823037P
Reference: ECH0182303
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01823017K

Anti-Streptolysin O (ASO) Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01823017K
Basic UDI-DI: B-ECH01823017K
Reference: ECH0182301
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01813037G

C-reactive protein (CRP) Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01813037G
Basic UDI-DI: B-ECH01813037G
Reference: ECH0181303
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01813017C

Anti-Streptolysin O (ASO) Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01813017C
Basic UDI-DI: B-ECH01813017C
Reference: ECH0181301
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ab Calibrators

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24297UC
Basic UDI-DI: B-A24297UC
Reference: A24297
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ag Calibrators

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24292U2
Basic UDI-DI: B-A24292U2
Reference: A24292
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems OP 300 High Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474985S3
Basic UDI-DI: B-474985S3
Reference: 474985
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems DAT Multi-Drug High Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474973RU
Basic UDI-DI: B-474973RU
Reference: 474973
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474020PS
Basic UDI-DI: B-474020PS
Reference: 474020
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-468429RH
Basic UDI-DI: B-468429RH
Reference: 468429
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465365QT
Basic UDI-DI: B-465365QT
Reference: 465365
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 20 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-464390QK
Basic UDI-DI: B-464390QK
Reference: 464390
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Protein Calibrator Levels 1 and 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450202NG
Basic UDI-DI: B-450202NG
Reference: 450202
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 3 Calibrator 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449730R2
Basic UDI-DI: B-449730R2
Reference: 449730
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 1 Calibrator 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-449560QZ
Basic UDI-DI: B-449560QZ
Reference: 449560
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details