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101 device results listed.

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DAT Screen

IVD generalIVDDOn the marketProfessional testing

Manufacturer: RED CELL BİYOTEKNOLOJİ A.Ş.
Manufacturer SRN: TR-MF-000026921
UDI-DI: 08682484709086
Basic UDI-DI: B-08682484709086
Reference: RCDAT
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 21:11

Manufacturer products View details

Neutral Gel

IVD generalIVDDOn the marketProfessional testing

Manufacturer: RED CELL BİYOTEKNOLOJİ A.Ş.
Manufacturer SRN: TR-MF-000026921
UDI-DI: 08682484709079
Basic UDI-DI: B-08682484709079
Reference: RCNEU
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 21:11

Manufacturer products View details

H Gel

IVD generalIVDDOn the marketProfessional testing

Manufacturer: RED CELL BİYOTEKNOLOJİ A.Ş.
Manufacturer SRN: TR-MF-000026921
UDI-DI: 08682484709062
Basic UDI-DI: B-08682484709062
Reference: RCH
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 21:11

Manufacturer products View details

A1 Gel

IVD generalIVDDOn the marketProfessional testing

Manufacturer: RED CELL BİYOTEKNOLOJİ A.Ş.
Manufacturer SRN: TR-MF-000026921
UDI-DI: 08682484709055
Basic UDI-DI: B-08682484709055
Reference: RCA1
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 08.07.2026 21:11

Manufacturer products View details

Neutr-AB II

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137341145
Basic UDI-DI: B-07640137341145
Reference: 213424
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 07.07.2026 05:41

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Rapid Quantitative Test（Fluorescence Immunoassay）

25Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: WWHS Biotech.Inc
Manufacturer SRN: CN-MF-000027179
UDI-DI: 06975068490282
Basic UDI-DI: B-06975068490282
Reference: CP068.B1
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

DAY LISS Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001802
Basic UDI-DI: 93543300310104LZ
Reference: 31010-4
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

DAY Bromelin Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330001345
Basic UDI-DI: 93543300320106MG
Reference: 32010-6
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

STARGEL10 STAR SOLUTION

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330000553
Basic UDI-DI: 93543300GT20118P
Reference: GT2011
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

STATUS1 Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Haemokinesis Ltd
Manufacturer SRN: AU-MF-000033867
UDI-DI: 09354330000058
Basic UDI-DI: 93543300TT1003DS
Reference: TT1003
EMDN: W0103030306
EMDN description: ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)
First on market country: Türkiye
Authorised representative: Compliance Management Solutions Europe LTD
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Automated C3d plate

Automated C3d Plate

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234002413
Basic UDI-DI: 88823401W0103030305C000SN
Reference: 0066260
EMDN: W0103030305
EMDN description: MONOSPECIFIC ANTIHUMAN SERUM
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-IgG,-C3d (Murine Monoclonal); Polyspecific, Gamma-clone

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001676
Basic UDI-DI: 88823401W0103030304C000SB
Reference: 0409703
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

H.P.C. (Human Platelet Concentrate)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001027
Basic UDI-DI: 88823401W01030399C030005L
Reference: 0057320
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

10888234001010

W.A.R.M.(Warm Autoantibody Removal Medium)

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001010
Basic UDI-DI: 88823401W0103030307C003TJ
Reference: W.A.R.M. (Warm Autoantibody Removal Medium)
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

RESt (Rabbit Erythrocyte Stroma)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234001003
Basic UDI-DI: 88823401W01030399C040005T
Reference: 0057316
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-Dried Papain

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000990
Basic UDI-DI: 88823401W0103030307C002TG
Reference: 0057292
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma ELU-KIT II

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000860
Basic UDI-DI: 88823401W01030399C020015F
Reference: 0007861
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma P1 Blood Group Substance

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000846
Basic UDI-DI: 88823401W01030399C0500164
Reference: 0007700
EMDN: W0103030399
EMDN description: ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GammaZyme-B

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000716
Basic UDI-DI: 88823401W0103030307C001TE
Reference: 0007058
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

GammaZyme-F

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immucor, Inc.
Manufacturer SRN: US-MF-000011568
UDI-DI: 10888234000709
Basic UDI-DI: 88823401W0103030307C000TC
Reference: 0007056
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Germany
Authorised representative: IMMUCOR Medizinische Diagnostik GmbH
Last updated: 03.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details