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Atellica IM total PSA II (tPSAII)

IVDR_67_TTN_DUB-C_C_REAG_KIT_hsPSA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414240138
Basic UDI-DI: 0405686902251VC
Reference: 11202246
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM total PSA II (tPSAII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414240145
Basic UDI-DI: 0405686902251VC
Reference: 11202247
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.09.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

HuayueKeju

4 bottles/box： 450ml/bottle，500ml/bottle

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Huayue Keju Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000057705
UDI-DI: 06978115480007
Basic UDI-DI: 697811548HYKJ001ZH
Reference: 450ml/bottle
EMDN: W0104010805
EMDN description: BUFFERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

HuayueKeju

BS-450;BS-500

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Huayue Keju Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000057705
UDI-DI: 06978115480021
Basic UDI-DI: 697811548HYKJ002ZK
Reference: BS-450
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

HuayueKeju

200 tests/box： 7ml/bottle, 7.5ml/bottle, 8ml/bottle, 8.5ml/bottle, 9ml/bottle, 9.5ml/bottle, 10ml/bottle, 10.5ml/bottle, 11ml/bottle, 11.5ml/bottle, 12ml/bottle, 12.5ml/bottle, 15ml/bottle, 16ml/bottle, etc

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Huayue Keju Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000057705
UDI-DI: 06978115480106
Basic UDI-DI: 697811548HYKJ003ZM
Reference: 10ml/bottle
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

HuayueKeju

2 bottles/box： 450ml / bottle, 500ml /bottle.

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Huayue Keju Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000057705
UDI-DI: 06978115480243
Basic UDI-DI: 697811548HYKJ004ZP
Reference: 450ml/bottle
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

06941967210047

IVD Class BNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967210047
Basic UDI-DI: 697326286001822A
Reference: 01.09.00.22.EC.01
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 22.09.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

04049095210099

RIDA®UNITY Parasitic Stool Panel II

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

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210099
Basic UDI-DI: 4049095UN17250000SF
Reference: UN1725
EMDN: W0105050299
EMDN description: PARASITOLOGY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 03:18

Manufacturer products View details

Panel 44 Peru

AllergyScreen®/AlleisaScreen®

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: MEDIWISS ANALYTIC GmbH Gesellschaft für angewandte in-vitro Analytik
Manufacturer SRN: DE-MF-000004992
UDI-DI: 04251342602612
Basic UDI-DI: B-04251342602612
Reference: 0261
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 03:17

Manufacturer products View details

00857031002059

C. DIFF QUIK CHEK COMPLETE

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: TECHLAB, Inc.
Manufacturer SRN: US-MF-000008412
UDI-DI: 00857031002059
Basic UDI-DI: 857031002CDIFFAGTOX001SJ
Reference: T30525C
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 22.09.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

C Reactive Protein (CRP) (Latex)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458514004GK
Basic UDI-DI: B-G458514004GK
Reference: 514 004
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

C Reactive Protein (CRP) (Latex)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458514003EK
Basic UDI-DI: B-G458514003EK
Reference: 514 003
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Multical

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458328002AM
Basic UDI-DI: B-G458328002AM
Reference: 328 002
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Multical

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G4583280018M
Basic UDI-DI: B-G4583280018M
Reference: 328 001
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Pathotrol

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458327002AM
Basic UDI-DI: B-G458327002AM
Reference: 327 002
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Pathotrol

IVD generalNot specifiedOn the market

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G4583270018M
Basic UDI-DI: B-G4583270018M
Reference: 327 001
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Normotrol

IVD generalNot specifiedOn the market

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458326002BK
Basic UDI-DI: B-G458326002BK
Reference: 326 002
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

SP-Normotrol

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G4583260019K
Basic UDI-DI: B-G4583260019K
Reference: 326 001
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:05

Manufacturer products Authorised representative products Authorised representative actors View details

06976612386006

1gE 1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jinan Deheng Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048173
UDI-DI: 06976612386006
Basic UDI-DI: B-06976612386006
Reference: IgE 1 test/kit
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

CeliaSCAN

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: Microbe&Lab B.V.
Manufacturer SRN: NL-MF-000005727
UDI-DI: 08719327031834
Basic UDI-DI: B-08719327031834
Reference: 2331633
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 22.09.2026 02:59

Manufacturer products View details