- Manufacturer
- Erba Lachema s.r.o.
- Manufacturer SRN
- CZ-MF-000024067
- UDI-DI
- 08592156078917
- Basic UDI-DI
- 8592156CCRE0028T7
- Reference
- XSYS0044
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- -
- Authorised representative
- -
- Last updated
- 08.07.2026 22:49
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
22.09.2026 04:45
Sync status
Successful
Device
3478295
Actor
47685
Certificate
3340
IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent
LDL KOLESTEROL DİREKT KİTİ
LDL CHOLESTEROL DIRECT REAGENT
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
- Manufacturer SRN
- TR-MF-000027166
- UDI-DI
- 08681812530668
- Basic UDI-DI
- B-08681812530668
- Reference
- 08V4920
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 08.07.2026 18:41
LDL KOLESTEROL DİREKT KİTİ
LDL CHOLESTEROL DIRECT REAGENT
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
- Manufacturer SRN
- TR-MF-000027166
- UDI-DI
- 08681812530651
- Basic UDI-DI
- B-08681812530651
- Reference
- 08V4925
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 08.07.2026 18:41
LDL Cholesterol Direct, R1 1 x 30 mL, R2 1 x 10 mL, Cal 1 x 1 mL
LDL Cholesterol Direct, R1 1 x 30 mL, R2 1 x 10 mL, CAL 1 x 1 mL
IVD generalIVDDOn the marketHuman tissuesKitReagentSingle use
- Manufacturer
- Chronolab Systems, S.L.
- Manufacturer SRN
- ES-MF-000017043
- UDI-DI
- D-084360387317319FR
- Basic UDI-DI
- B-084360387317319FR
- Reference
- 101-0535
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 08.07.2026 00:31
LDL Cholesterol Direct, R1 1 x 60 mL, R2 1 x 20 mL, CAL 1 x 1 mL
LDL Cholesterol Direct, R1 1 x 60 mL, R2 1 x 20 mL, CAL 1 x 1 mL
IVD generalIVDDOn the marketHuman tissuesKitReagentSingle use
- Manufacturer
- Chronolab Systems, S.L.
- Manufacturer SRN
- ES-MF-000017043
- UDI-DI
- D-084360387147148FV
- Basic UDI-DI
- B-084360387147148FV
- Reference
- 101-0516
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 08.07.2026 00:31
08435287115796
CHOLESTEROL LDL PRECIPITATING REAGENT
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287115796
- Basic UDI-DI
- B-08435287115796
- Reference
- 11579
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:47
08435287112429
CHOLESTEROL LDL DIRECT [TOOS]
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287112429
- Basic UDI-DI
- B-08435287112429
- Reference
- 21785
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:46
08435287111743
CHOLESTEROL LDL DIRECT [TOOS]
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287111743
- Basic UDI-DI
- B-08435287111743
- Reference
- 23785
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:46
08435287111736
CHOLESTEROL LDL DIRECT [TOOS]
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287111736
- Basic UDI-DI
- B-08435287111736
- Reference
- 12785
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:46
08435287111729
CHOLESTEROL LDL DIRECT [TOOS]
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287111729
- Basic UDI-DI
- B-08435287111729
- Reference
- 11785
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:45
COLESTEROL-LDL DIRECTO
COLESTEROL-LDL DIRECTO
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- QUIMICA CLINICA APLICADA S.A.
- Manufacturer SRN
- ES-MF-000001512
- UDI-DI
- 08430155009948
- Basic UDI-DI
- B-08430155009948
- Reference
- 991880
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:27
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- GIESSE DIAGNOSTICS SRL
- Manufacturer SRN
- IT-MF-000039031
- UDI-DI
- 08053172972615
- Basic UDI-DI
- B-08053172972615
- Reference
- BT0025
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Italy
- Authorised representative
- -
- Last updated
- 07.07.2026 19:48
Colesterolo LDL
0025
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- GIESSE DIAGNOSTICS SRL
- Manufacturer SRN
- IT-MF-000039031
- UDI-DI
- 08053172970284
- Basic UDI-DI
- B-08053172970284
- Reference
- 0025
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Italy
- Authorised representative
- -
- Last updated
- 07.07.2026 19:42
Low Density Lipoprotein Cholesterol Kit(Direct Method)
"R1:1x60ml R2:2x10ml "
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Coei Biotech Co.Ltd.
- Manufacturer SRN
- CN-MF-000049509
- UDI-DI
- 06977565585430
- Basic UDI-DI
- B-06977565585430
- Reference
- 5432
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- France
- Authorised representative
- Medunion S.L.
- Last updated
- 07.07.2026 01:22
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000042656
- UDI-DI
- 06975838801584
- Basic UDI-DI
- B-06975838801584
- Reference
- C002
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Italy
- Authorised representative
- Sungo Cert GmbH
- Last updated
- 07.07.2026 00:13
06975225460561
R1: 80 mL×3; R2: 80 mL×1
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- Manufacturer SRN
- CN-MF-000028832
- UDI-DI
- 06975225460561
- Basic UDI-DI
- B-06975225460561
- Reference
- DTSH060412
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 06.07.2026 22:09
06975225460554
R1: 60 mL×4; R2: 20 mL×4
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- Manufacturer SRN
- CN-MF-000028832
- UDI-DI
- 06975225460554
- Basic UDI-DI
- B-06975225460554
- Reference
- DTSH060403
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 06.07.2026 22:09
06975225460547
R1: 60 mL×3; R2: 60 mL×1
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- Manufacturer SRN
- CN-MF-000028832
- UDI-DI
- 06975225460547
- Basic UDI-DI
- B-06975225460547
- Reference
- DTSH060411
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 06.07.2026 22:08
06975225460530
R1: 60 mL×2; R2: 20 mL×2
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- Manufacturer SRN
- CN-MF-000028832
- UDI-DI
- 06975225460530
- Basic UDI-DI
- B-06975225460530
- Reference
- DTSH060410
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 06.07.2026 22:08
06975225460523
R1: 30 mL×3; R2: 30 mL×1
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- Manufacturer SRN
- CN-MF-000028832
- UDI-DI
- 06975225460523
- Basic UDI-DI
- B-06975225460523
- Reference
- DTSH060409
- EMDN
- W01010221
- EMDN description
- LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 06.07.2026 22:08