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AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189282896
Basic UDI-DI: 45601892100040017F
Reference: 0019945
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S KRYPTOR BUFFER

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638990
Basic UDI-DI: 426015763899BKBUFFER0XXUR
Reference: 89970
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S KRYPTOR compact DILCUP

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638983
Basic UDI-DI: 426015763899BKCDILCUPXXU8
Reference: 89985
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S KRYPTOR compact REACT

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638976
Basic UDI-DI: 426015763899BKCREACT0XXQV
Reference: 89986
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S Reaction Plates KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638969
Basic UDI-DI: 426015763899BKReaPlaGXXG2
Reference: 89996
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S Dilution Plates KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638952
Basic UDI-DI: 426015763899BKDilPlaGXXE7
Reference: 89995
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S Solution 2 KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638631
Basic UDI-DI: 426015763899BSol2KG00XXUX
Reference: 89992
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S Solution 1 KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638624
Basic UDI-DI: 426015763899BSol1KG00XXUE
Reference: 89991
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S Solution 4 KRYPTOR GOLD

B·R·A·H·M·S Solutions 3 and 4 KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638488
Basic UDI-DI: 426015763899BSol3-4KGXXLM
Reference: 89994
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S KRYPTOR compact SOLUTION 3

B·R·A·H·M·S KRYPTOR compact SOLUTIONS 3 and 4

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157633230
Basic UDI-DI: 426015763899BKCSol3-4XXFT
Reference: 89983
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S KRYPTOR compact SOLUTION 1

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157633216
Basic UDI-DI: 426015763899BKCSol100XXF6
Reference: 89981
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:38

Manufacturer products View details

B·R·A·H·M·S KRYPTOR GOLD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630123
Basic UDI-DI: 426015763BMKSYS020BKGXXPA
Reference: BMKSYS0201
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S KRYPTOR DISK-ANA

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631373
Basic UDI-DI: 426015763105105BKDA00XXZ7
Reference: 105105
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

B·R·A·H·M·S KRYPTOR compact PLUS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630949
Basic UDI-DI: 426015763106172BKC+00XXWW
Reference: 106172
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

VIDAS® 3 ASSAY DILUTION CUP

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026612849
Basic UDI-DI: 357302BUDI000296TT
Reference: 542653
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

Manufacturer products View details

IMMAGE 800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265403
Basic UDI-DI: 150995901A15445PU
Reference: A15445
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access 2 Immunoassay System

81600N

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265380
Basic UDI-DI: 150995901Acc2FR
Reference: 81600N
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

UniCel DxI 800 Access Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590265373
Basic UDI-DI: 150995901UniCelDxI8Z
Reference: 973100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic single molecular immunity Detection (SMID) analyzer AST-Dx90

AST-Dx90

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Astrabio Technology Co., Ltd.
Manufacturer SRN: CN-MF-000041763
UDI-DI: 06977100860244
Basic UDI-DI: 697710086ASTMYN9
Reference: 8901000100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289820028
Basic UDI-DI: 69332898CE2001EG
Reference: WP13
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details