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IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341466
Basic UDI-DI: 764013734DataExtend0.8WB
Reference: 213685
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-P1 Mono-Type Dual

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341435
Basic UDI-DI: 764013734Antis-C-131LZ
Reference: 213292
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Leb for DG Gel

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341428
Basic UDI-DI: 764013734Antis-C-105LY
Reference: 213284
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Lea for DG Gel

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341411
Basic UDI-DI: 764013734Antis-C-104LW
Reference: 213283
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

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Diego(a)-Cyte 3%

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341374
Basic UDI-DI: 764013734Diego3UN
Reference: 213803
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Diego(a)-Cyte 0.8%

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341367
Basic UDI-DI: 764013734Diego0.8SK
Reference: 213802
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-C3d

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341053
Basic UDI-DI: 764013734Antis-C-125M6
Reference: 213566
EMDN: W0103030305
EMDN description: MONOSPECIFIC ANTIHUMAN SERUM
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Dia Dual

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340704
Basic UDI-DI: 764013734Antis-C-128MC
Reference: 213229
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-s Mono-Type

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340674
Basic UDI-DI: 764013734Antis-C-110LR
Reference: 213994
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-S Mono-Type

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340667
Basic UDI-DI: 764013734Antis-C-109M8
Reference: 213993
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-N (LN3/MN879) Mono-Type

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340650
Basic UDI-DI: 764013734Antis-C-135M9
Reference: 213989
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-M Mono-Type Dual

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340643
Basic UDI-DI: 764013734Antis-C-133M5
Reference: 213008
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Kpb Dual

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340636
Basic UDI-DI: 764013734Antis-C-127MA
Reference: 213996
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Kpa Dual

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340629
Basic UDI-DI: 764013734Antis-C-126M8
Reference: 213995
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-k (Cellano) Mono-Type

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340483
Basic UDI-DI: 764013734Antis-C-118M9
Reference: 213209
EMDN: W0103030501
EMDN description: OTHER ANTIGEN TYPING REAGENTS
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 31.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

16975631347019

Nucleic Acid Extraction or Purification Reagent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU COMEON MEDICAL APPARATUS CO., LTD
Manufacturer SRN: CN-MF-000018384
UDI-DI: 16975631347019
Basic UDI-DI: 697563134KM007G4
Reference: N/A
EMDN: W0104080604
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Rapid Test

FLU-522b-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910673
Basic UDI-DI: 69798909110006CP
Reference: FLU-522b-25M
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A&B/SARS-CoV-2 Antigen Combo Test

RVC-532b-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910666
Basic UDI-DI: 69798909110004CK
Reference: RVC-532b-25M
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

8-in-1 Respiratory Antigen Combo Rapid Test

RVC-585b-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910659
Basic UDI-DI: 69798909110057D8
Reference: RVC-585b-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details

10-in-1 Respiratory Antigen Combo Rapid Test

RVC-5105a-25M

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: 06979890910642
Basic UDI-DI: 69798909110058DA
Reference: RVC-5105a-25M
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 31.07.2026 21:54

Manufacturer products Authorised representative products Authorised representative actors View details