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22 device results listed.

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SAS-1 Cholesterol Profile Kit

200601

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013009238
Basic UDI-DI: B-05056013009238
Reference: 200601
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 06.07.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE IFE Diluent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025832
Basic UDI-DI: 505601300CEIFEDIL3S
Reference: V8150
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE Immunodisplacement

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025825
Basic UDI-DI: 505601300ULTCEIDCG
Reference: V8140
EMDN: W0102010110
EMDN description: IMMUNOELECTROPHORESIS KITS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE Urine Prep

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025818
Basic UDI-DI: 505601300ULTCEURPREPXK
Reference: V130
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunotyping Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025801
Basic UDI-DI: 505601300ULTCEIDCONTKN
Reference: V150
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Protein Normal Control

CE Serum Protein Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025788
Basic UDI-DI: 505601300ULTCESPCONTTU
Reference: V110
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE Maintenance Buffer

CE Maintenance and Storage Buffers

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025764
Basic UDI-DI: 505601300ULTCEBUFS5Z
Reference: V8010
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

V8 UltraCE

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025757
Basic UDI-DI: 505601300V8ULTRACE3Z
Reference: V801
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE Serum Protein

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025689
Basic UDI-DI: 505601300ULTCESPE6
Reference: V8100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

Thromboplastin L

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013016557
Basic UDI-DI: 505601300PTMR
Reference: 5265L
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-MX SP-10 Kit

Serum Protein Kits

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013007944
Basic UDI-DI: 5056013005BANDM8
Reference: 100100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Protein Abnormal Control

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025795
Basic UDI-DI: 505601300ULTCESPCONTTU
Reference: V120
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: France
Authorised representative: Advena Limited
Last updated: 19.06.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

UltraCE Storage Buffer

IVD Class ANot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025771
Basic UDI-DI: 505601300ULTCEBUFS5Z
Reference: V8020
EMDN: W0201050101
EMDN description: AUTOMATED ELECTROPHORESIS SYSTEMS
First on market country: France
Authorised representative: Advena Limited
Last updated: 19.06.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

Thromboplastin L

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013017424
Basic UDI-DI: 505601300PTMR
Reference: 5265HL
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

Thromboplastin L

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013016779
Basic UDI-DI: 505601300PTMR
Reference: 5267L
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Ireland
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 180 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011569
Basic UDI-DI: 5056013005BANDM8
Reference: 3147
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 300 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011552
Basic UDI-DI: 5056013005BANDM8
Reference: 3146
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

REP/SPIFE SP 600 Kit

IVD Class CNot specifiedNot intended for EU market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013011538
Basic UDI-DI: 5056013005BANDM8
Reference: 3145
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-3 SP-60 Kit

IVD Class CNot specifiedOn the market

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013010517
Basic UDI-DI: 5056013005BANDM8
Reference: 300100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-1 Cholesterol Profile Kit

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013009245
Basic UDI-DI: B-05056013009245
Reference: 200602
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 19.06.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details