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EUDAMED Device Search

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TREN

Last updated

23.09.2026 04:15

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Device

3540602

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47793

Certificate

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Active filter:EMDN:W010217

39 device results listed.

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Sangtec-100 Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN
CN-MF-000001891
UDI-DI
06925794571403
Basic UDI-DI
B-06925794571403
Reference
3013431
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Austria
Authorised representative
Emergo Europe B.V.
Last updated
21.09.2026 17:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Glial Fibrillary Acidic Protein (GFAP) Test Kit (CLIA)

Glial Fibrillary Acidic Protein (GFAP) Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingSingle use
Manufacturer
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN
CN-MF-000010710
UDI-DI
D-CI-GFAP(AT)ME
Basic UDI-DI
B-CI-GFAP(AT)ME
Reference
CI-GFAP
EMDN
W01021701
EMDN description
GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country
Germany
Authorised representative
VidaQuick Biotech S.L.
Last updated
21.09.2026 17:12
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Central Nervous System Specific Protein S100β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289858328
Basic UDI-DI
B-06933289858328
Reference
W498P0001
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
09.08.2026 23:21
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Central Nervous System Specific Protein S100β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289858359
Basic UDI-DI
B-06933289858359
Reference
W498P0004
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 18:19
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Central Nervous System Specific Protein S100β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289858342
Basic UDI-DI
B-06933289858342
Reference
W498P0003
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 18:19
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SmarLumi

Central Nervous System Specific Protein S100β (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN
CN-MF-000000689
UDI-DI
06933289858335
Basic UDI-DI
B-06933289858335
Reference
W498P0002
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
05.08.2026 14:20
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Sangtec-100 Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN
CN-MF-000001891
UDI-DI
06942202224324
Basic UDI-DI
B-06942202224324
Reference
3014258
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Austria
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 16:51
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Sangtec-100 Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN
CN-MF-000001891
UDI-DI
06925794571410
Basic UDI-DI
B-06925794571410
Reference
3013435
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Austria
Authorised representative
Emergo Europe B.V.
Last updated
03.08.2026 09:38
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
VIDAS® TBI (GFAP, UCH-L1)

VIDAS® TBI (GFAP, UCH-L1)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
bioMérieux SA
Manufacturer SRN
FR-MF-000004436
UDI-DI
03573026626884
Basic UDI-DI
357302BUDI002001SS
Reference
423615-30
EMDN
W01021701
EMDN description
GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:04
Manufacturer productsView details
VIDAS® TBI (GFAP, UCH-L1)

VIDAS® TBI (GFAP, UCH-L1)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
bioMérieux SA
Manufacturer SRN
FR-MF-000004436
UDI-DI
03573026613860
Basic UDI-DI
357302BUDI002001SS
Reference
423615
EMDN
W01021701
EMDN description
GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1
First on market country
France
Authorised representative
-
Last updated
30.07.2026 20:58
Manufacturer productsView details
LIAISON® S100

LIAISON® S100

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
DiaSorin Italia S.p.A.
Manufacturer SRN
IT-MF-000029422
UDI-DI
08056771200509
Basic UDI-DI
B-08056771200509
Reference
314701
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Italy
Authorised representative
-
Last updated
23.07.2026 01:40
Manufacturer productsView details
S100β Protein Detection Kit (Immunofluorescence Chromatography）

S100β Protein Detection Kit (Immunofluorescence Chromatography）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000044128
UDI-DI
D-GKPD196Y5
Basic UDI-DI
B-GKPD196Y5
Reference
GKPD196
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
14.07.2026 00:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-811044P5

S100 β Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024153
UDI-DI
D-811044P5
Basic UDI-DI
B-811044P5
Reference
811044
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-811033NY

Human β-Amyloid (Aβ1-42) Rapid Detect

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024153
UDI-DI
D-811033NY
Basic UDI-DI
B-811033NY
Reference
811033
EMDN
W01021799
EMDN description
OTHER TRAUMATIC BRAIN INJURY MARKERS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
D-811032NW

Human β-Amyloid (Aβ1-42) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024153
UDI-DI
D-811032NW
Basic UDI-DI
B-811032NW
Reference
811032
EMDN
W01021799
EMDN description
OTHER TRAUMATIC BRAIN INJURY MARKERS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
12.07.2026 09:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
S100 Protein Test Kit (CLIA)

S100 Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
20850076346373
Basic UDI-DI
B-20850076346373
Reference
CLS100-301a
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 15:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
S100 Protein Test Kit (CLIA)

S100 Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Healgen Life Science LLC
Manufacturer SRN
US-MF-000043017
UDI-DI
10850076346376
Basic UDI-DI
B-10850076346376
Reference
CLS100-301a
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Ireland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 04:39
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06978896415960

40 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN
CN-MF-000019908
UDI-DI
06978896415960
Basic UDI-DI
B-06978896415960
Reference
W-IF2-S100-β-40
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 01:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06978896415953

20 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN
CN-MF-000019908
UDI-DI
06978896415953
Basic UDI-DI
B-06978896415953
Reference
W-IF2-S100-β-20
EMDN
W01021702
EMDN description
PROTEIN S-100 B
First on market country
Romania
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
07.07.2026 01:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details