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216 device results listed.

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Pentra C200 ISE

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006672
Basic UDI-DI: 361023pentra_c2006U
Reference: 1280090002
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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Pentra C400 Standard

Pentra C400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006542
Basic UDI-DI: 361023pentra_c40076
Reference: 1280241012
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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Pentra XLR

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006405
Basic UDI-DI: 361023pentra_xlrEA
Reference: 1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra XL80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230006399
Basic UDI-DI: 361023pentra_xl80LB
Reference: 1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Dummy-E

A11A01851

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005873
Basic UDI-DI: 361023pentra_dummy_eU5
Reference: A11A01851
EMDN: W0580
EMDN description: IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra ISE Cleaner CP

A11A01971

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005798
Basic UDI-DI: 361023pentra_ise_cleanQS
Reference: A11A01971
EMDN: W0101070399
EMDN description: REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Calcium AS CP

A11A01954

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005750
Basic UDI-DI: 361023pentra_calcium_asM6
Reference: A11A01954
EMDN: W01010303
EMDN description: CALCIUM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Creatinine 120 CP

A11A01933

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005736
Basic UDI-DI: 361023pentra_creat120J3
Reference: A11A01933
EMDN: W01010207
EMDN description: CREATININE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Etching CP

A11A01769

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005514
Basic UDI-DI: 361023pentra_etchingNN
Reference: A11A01769
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Clean-Chem CP

A11A01755

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005491
Basic UDI-DI: 361023pentra_clean_chemHQ
Reference: A11A01755
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Deproteinizer CP

A11A01754

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005484
Basic UDI-DI: 361023pentra_deprotHD
Reference: A11A01754
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Uric Acid CP

A11A01670

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005231
Basic UDI-DI: 361023pentra_uric_acidYJ
Reference: A11A01670
EMDN: W01010232
EMDN description: URIC ACID
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Glucose PAP CP

A11A01668

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005217
Basic UDI-DI: 361023pentra_glu_papRC
Reference: A11A01668
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Glucose HK CP

A11A01667

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005200
Basic UDI-DI: 361023pentra_glu_hkJ3
Reference: A11A01667
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Phosphorus CP

A11A01665

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005194
Basic UDI-DI: 361023pentra_phosphorusKU
Reference: A11A01665
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

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ABX Pentra Urea CP

A11A01641

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005040
Basic UDI-DI: 361023pentra_ureaSX
Reference: A11A01641
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

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ABX Pentra Triglycerides CP

A11A01640

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005033
Basic UDI-DI: 361023pentra_triglyR5
Reference: A11A01640
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

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ABX Pentra LDL Direct CP

A11A01638

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005019
Basic UDI-DI: 361023pentra_ldl_dFF
Reference: A11A01638
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

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ABX Pentra HDL Direct CP

A11A01636

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004999
Basic UDI-DI: 361023pentra_hdl_directN8
Reference: A11A01636
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

ABX Pentra Ferritin Cal

A11A01619

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004852
Basic UDI-DI: 361023pentra_ferr_calZS
Reference: A11A01619
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details