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ABX Pentra Urinary Proteins CP

A11A01642

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005057
Basic UDI-DI: B-03610230005057
Reference: A11A01642
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 13:36

Manufacturer products View details

MP 100

MICROPROTEIN

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156109338
Basic UDI-DI: 8592156CCRE0031SU
Reference: BLT00045
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

UA 500

URIC ACID AOD

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156097734
Basic UDI-DI: 8592156CCRE0035T4
Reference: BLT00063
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

LDL C DIRECT 240

LDL CHOLESTEROL DIRECT

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156097659
Basic UDI-DI: 8592156CCRE0029T9
Reference: BLT00042
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

HDL C DIRECT 240

HDL CHOLESTEROL DIRECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156097611
Basic UDI-DI: 8592156CCRE0027T5
Reference: BLT00030
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:29

Manufacturer products View details

UIBC 125

UIBC

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156085335
Basic UDI-DI: 8592156CCRE0037T8
Reference: XSYS0050
EMDN: W01010217
EMDN description: IRON BINDING CAPACITY - TOTAL (CC)
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

UA SINGLE 200

URIC ACID (SINGLE REAGENT)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156080989
Basic UDI-DI: 8592156CCRE0034T2
Reference: BLT00062
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

TG 100

TRIGLYCERIDES

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156080927
Basic UDI-DI: 8592156CCRE0032SW
Reference: BLT00057
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

TP 500

TOTAL PROTEIN

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156080897
Basic UDI-DI: 8592156CCRE0030SS
Reference: BLT00055
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

UREA 275

UREA

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156079747
Basic UDI-DI: 8592156CCRE0019T6
Reference: XSYS0020
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

UA 275

URIC ACID

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156079730
Basic UDI-DI: 8592156CCRE0033SY
Reference: XSYS0021
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

LDL 80

LDL DIRECT

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156078894
Basic UDI-DI: 8592156CCRE0028T7
Reference: BLT00041
EMDN: W01010221
EMDN description: LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

HDL 80

HDL DIRECT

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Erba Lachema s.r.o.
Manufacturer SRN: CZ-MF-000024067
UDI-DI: 08592156078856
Basic UDI-DI: 8592156CCRE0026T3
Reference: BLT00028
EMDN: W01010215
EMDN description: HIGH DENSITY LIPOPROTEIN CHOLESTEROL
First on market country: Czechia
Authorised representative: -
Last updated: 16.07.2026 12:28

Manufacturer products View details

06977338230031

Glucose Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230031
Basic UDI-DI: 697733823000EDL
Reference: C21-GL100
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

06971771200026

LPM-102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200026
Basic UDI-DI: 697177120LPM102HX
Reference: LPM-102
EMDN: W01010228
EMDN description: TOTAL LIPIDS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ischemia Modified Albumin (ACB)

Ischemia Modified Albumin (ACB)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555580
Basic UDI-DI: 69471455599XD
Reference: 130504007A
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Zinc (PAPS)

Zinc (PAPS)

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145548995
Basic UDI-DI: 69471455565WU
Reference: 130509006S
EMDN: W01010233
EMDN description: ZINC
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Ammonia (Glutamate dehydrogenase)

Ammonia (Glutamate dehydrogenase)

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145511180
Basic UDI-DI: 69471455541WE
Reference: 130502010S
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem TP

Automatic Chemistry Analyzer

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253000120
Basic UDI-DI: 69422530000002N2
Reference: 360101TP0000S
EMDN: W01010230
EMDN description: TOTAL PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose Meter Plus

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510464
Basic UDI-DI: 0810164510012N8
Reference: EQB02ST-GL
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details