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117 device results listed.

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Bromelase 30

IVD generalIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Medion Grifols Diagnostics AG
Manufacturer SRN: CH-MF-000024272
UDI-DI: 07640137340681
Basic UDI-DI: B-07640137340681
Reference: 213578
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Spain
Authorised representative: Diagnostic Grifols, S.A.
Last updated: 05.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-human globulin polyspecific

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673700515
Basic UDI-DI: B-08431673700515
Reference: 1700051
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:16

Manufacturer products View details

Odczynnik anty-IgG

Anti-IgG reagent

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620222
Basic UDI-DI: B-05904365620222
Reference: 899
EMDN: W0103030305
EMDN description: MONOSPECIFIC ANTIHUMAN SERUM
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:20

Manufacturer products View details

Surowica Antyglobulinowa Poliwalentna (10x10ml)

Polyvalent anti-human globulin serum (10x10ml)

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620215
Basic UDI-DI: B-05904365620215
Reference: 912
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:20

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Surowica Antyglobulinowa Poliwalentna (1x5ml)

Polyvalent anti-human globulin serum (1x5ml)

IVD Annex II List BIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620208
Basic UDI-DI: B-05904365620208
Reference: 103/1
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:20

Manufacturer products View details

Surowica Antyglobulinowa Poliwalentna (10x5ml)

Polyvalent anti-human globulin serum (10x5ml)

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620192
Basic UDI-DI: B-05904365620192
Reference: 103/10
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:20

Manufacturer products View details

Papaina ST

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620147
Basic UDI-DI: B-05904365620147
Reference: 107
EMDN: W0103030307
EMDN description: ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

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Standaryzowane Krwinki Wzorcowe typ LISS-VERA do wykrywania przeciwciał

Standardized Red Blood Cells. Set type LISS-VERA for the antibodies detection

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620086
Basic UDI-DI: B-05904365620086
Reference: 512
EMDN: W0103030308
EMDN description: ANTIBODY 3 CELL SCREENING
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

Manufacturer products View details

Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał PLUS

Preserved Standard Red Blood Cells. Set for the antibody identification PLUS

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620055
Basic UDI-DI: B-05904365620055
Reference: 913
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

Manufacturer products View details

Konserwowane Krwinki Wzorcowe do identyfikacji przeciwciał

Preserved Standard Red Blood Cells. Set for the antibody identification

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620048
Basic UDI-DI: B-05904365620048
Reference: 510
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

Manufacturer products View details

Konserwowane Krwinki Wzorcowe do wykrywania przeciwciał

Preserved Standard Red Blood Cells. Set for the antibodies detection

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach
Manufacturer SRN: PL-MF-000037642
UDI-DI: 05904365620031
Basic UDI-DI: B-05904365620031
Reference: 509
EMDN: W0103030308
EMDN description: ANTIBODY 3 CELL SCREENING
First on market country: Poland
Authorised representative: -
Last updated: 02.08.2026 23:19

Manufacturer products View details

Monospecific Anti-Human IgG

Z356

IVD Annex II List BIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242472268
Basic UDI-DI: B-05060242472268
Reference: Z356
EMDN: W0103030305
EMDN description: MONOSPECIFIC ANTIHUMAN SERUM
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Polyspecific Anti-Human Globulin Reagent

Z350

IVD Annex II List BIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242472251
Basic UDI-DI: B-05060242472251
Reference: Z350
EMDN: W0103030304
EMDN description: POLYSPECIFIC ANTIHUMAN SERUM
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAcyte® Reagent Red Cells for Antibody Identification (papainised)

Z472

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242470806
Basic UDI-DI: B-05060242470806
Reference: Z472
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAcyte® RhD Negative CAT Reagent Red Cells for Antibody Screening

Z466

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242470776
Basic UDI-DI: B-05060242470776
Reference: Z466
EMDN: W0103030308
EMDN description: ANTIBODY 3 CELL SCREENING
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAcyte® Reagent Red Cells for Antibody Identification (native)

Z471

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242470790
Basic UDI-DI: B-05060242470790
Reference: Z471
EMDN: W0103030303
EMDN description: ANTIBODY IDENTIFICATION CELL PANELS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

ALBAcyte® Reagent Red Cells for Antibody Screening,

Z451

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Alba Bioscience Limited
Manufacturer SRN: GB-MF-000029300
UDI-DI: 05060242470721
Basic UDI-DI: B-05060242470721
Reference: Z451
EMDN: W0103030308
EMDN description: ANTIBODY 3 CELL SCREENING
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

Mi(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: 07640137341534
Basic UDI-DI: 764013734Mia0.8JK
Reference: 213386
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

Data-Cyte Extend 0.8%

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

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