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Urine CartiLaps® (CTX-II) EIA

AC-10F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690172
Basic UDI-DI: 5060169690172WR
Reference: AC-10F1
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha CrossLaps® (CTX-I) ELISA

AC-04F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690165
Basic UDI-DI: 5060169690165WU
Reference: AC-04F1
EMDN: W0102060317
EMDN description: PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Serum CrossLaps® (CTX-I) ELISA

AC-02F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690134
Basic UDI-DI: 5060169690134WH
Reference: AC-02F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

1,25-Dihydroxy Vitamin D EIA

AC-62F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690097
Basic UDI-DI: 5060169690097X4
Reference: AC-62F1
EMDN: W0102060308
EMDN description: 1.25-DIHYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine BETA CrossLaps® (CTX-I) ELISA

AC-05F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690158
Basic UDI-DI: 5060169690158WX
Reference: AC-05F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine CrossLaps® (CTX-I) EIA

AC-03F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690141
Basic UDI-DI: 5060169690141WE
Reference: AC-03F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Ostase® BAP EIA

AC-20F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690059
Basic UDI-DI: 5060169690059WU
Reference: AC-20F1
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

1,25-Dihydroxy Vitamin D RIA

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690028
Basic UDI-DI: 5060169690028WH
Reference: AA-54F2
EMDN: W0102060308
EMDN description: 1.25-DIHYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi HbA1c N HA-421W

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921008348
Basic UDI-DI: 4931921IVD0013NS
Reference: HA-421W
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Calcitonin RIA

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157635296
Basic UDI-DI: 426015763529BCalcitoRXXPU
Reference: 529.096
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:35

Manufacturer products View details

B·R·A·H·M·S MR-proADM II KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632516
Basic UDI-DI: 426015763847BADMIIK00XX5B
Reference: 847050N
EMDN: W0102069017
EMDN description: MID-REGIONAL PROADRENOMEDULLIN (MR-PROADM)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:35

Manufacturer products View details

B·R·A·H·M·S MR-proADM KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632080
Basic UDI-DI: 426015763829BMRprADMKXX3N
Reference: 829050N
EMDN: W0102069017
EMDN description: MID-REGIONAL PROADRENOMEDULLIN (MR-PROADM)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S PCT sensitive KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632035
Basic UDI-DI: 426015763825BPCTsensKXXAD
Reference: 825050N
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S PCT-Q

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631779
Basic UDI-DI: 426015763106BPCT-Q000XXJJ
Reference: 106025N
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

04099466400215

Extraction buffer (10x)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Seramun Diagnostica GmbH
Manufacturer SRN: DE-MF-000026029
UDI-DI: 04099466400215
Basic UDI-DI: 4099466ACS002NY
Reference: ACS-002
EMDN: W0102069009
EMDN description: ELASTASE (PANCREATIC POLYPEPTIDE)
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:26

Manufacturer products View details

VITAMIN D

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700807407
Basic UDI-DI: 37017008VITD03FB
Reference: VITD-0250
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:49

Manufacturer products View details

VIDAS® NEPHROCLEAR™ CCL14

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623418
Basic UDI-DI: 357302BUDI000908U7
Reference: 423961-03
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

Manufacturer products View details

VIDAS® NEPHROCHECK®

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026617387
Basic UDI-DI: 357302BUDI000859UK
Reference: 421172-03
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:04

Manufacturer products View details

VIDAS® NEPHROCLEAR™ CCL14

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026623401
Basic UDI-DI: 357302BUDI000908U7
Reference: 423961
EMDN: W0102060299
EMDN description: RENAL METABOLISM TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:59

Manufacturer products View details

VIDAS® PTH (1-84)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026601560
Basic UDI-DI: 357302BUDI000860U4
Reference: 422010
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details