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ADVIA 120/2120/2120i® DIFF TIMEpac

IVDR_67_TTN_DUB-C_A_REAG_DIFF TIMEPAC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414222899
Basic UDI-DI: 0405686900786WA
Reference: 10312270
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA® 120/2120/2120i CBC TIMEpac

IVDR_67_TTN_DUB-C_A_REAG_CBC TIMEPAC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414222882
Basic UDI-DI: 0405686900776W7
Reference: 10312269
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Tech-Cal

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 10815762021609
Basic UDI-DI: 0081576202TCV11SK
Reference: TCV11
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:21

Manufacturer products Authorised representative products Authorised representative actors View details

R&D Retic-I

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762021220
Basic UDI-DI: 0081576202RI00QM
Reference: RI001
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

R&D Retic

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testing

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762021206
Basic UDI-DI: 0081576202RE00PZ
Reference: RE003
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

G580XZ30011E

Cryophore™ Pleural Fluid 1

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: G580XZ30011E
Basic UDI-DI: ++G580XZ30012R
Reference: XZ3001
EMDN: W0103010301
EMDN description: HISTO / CYTO STAINS
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

++G580XZ30041H

Cryophore™ Ascitic Fluid

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: ++G580XZ30041H
Basic UDI-DI: ++G580XZ30042X
Reference: XZ3004
EMDN: W0103010301
EMDN description: HISTO / CYTO STAINS
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

++G580XZ30031G

Cryophore™ Pleural Fluid 3

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: X-ZELL Biotech Pte. Ltd.
Manufacturer SRN: SG-MF-000039227
UDI-DI: ++G580XZ30031G
Basic UDI-DI: ++G580XZ30032V
Reference: XZ3003
EMDN: W0103010301
EMDN description: HISTO / CYTO STAINS
First on market country: Germany
Authorised representative: X-ZELL Biotech GmbH
Last updated: 15.07.2026 21:20

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ENNOLIFE HbA1c Disc

HCA-TE-300

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322001218B
Basic UDI-DI: ++G322G322001218BL8MB
Reference: 001-218B
EMDN: W0103010699
EMDN description: HAEMATOLOGY RAPID TESTS & POINT OF CARE - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

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AGG/PAK™ 5 Combo Kit

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561076501/$$1126414000XXX*
Basic UDI-DI: ++G05610765056
Reference: 107650
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

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LTA Check Test Kit

LTA Check Test Kit (Performance Monitoring)