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Last updated

01.08.2026 16:25

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Device

2989422

Actor

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Certificate

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Active filter:EMDN:W01030201

378 device results listed.

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Thrombin Time (TT) Assay Kit (Clotting Method)

105-023619-00、105-023620-00、105-023621-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053025379
Basic UDI-DI
69449040AB75000035P
Reference
105-023619-00
EMDN
W0103020103
EMDN description
THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method)

105-023616-00、105-023617-00、105-023618-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053025348
Basic UDI-DI
69449040AB75000045R
Reference
105-023616-00
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Prothrombin Time (PT) Assay Kit (Clotting Method)

105-023613-00、105-023614-00、105-023615-00

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053025317
Basic UDI-DI
69449040AB75000055T
Reference
105-023613-00
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:48
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06926802612613

Prothrombin Time

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802612613
Basic UDI-DI
69268026MD85U0000000001JC
Reference
MCC00203E
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
Netherlands
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06926802603901

Kaolin Activation Reagent

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802603901
Basic UDI-DI
69268026MD66B00001W7
Reference
MCT00201E
EMDN
W0103020199
EMDN description
GENERAL COAGULATION TESTS - OTHER
First on market country
Netherlands
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06926802603819

Rapid Kaolin Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802603819
Basic UDI-DI
69268026MD66E00001XE
Reference
MCT00401E
EMDN
W0103020199
EMDN description
GENERAL COAGULATION TESTS - OTHER
First on market country
Netherlands
Safety summary (SSCP/SSP)
MD71-6-T25 · Rev. V2.0
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details
06926802603505

Prothrombin Time

IVD Class CIVDR 2017/746No longer on the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN
CN-MF-000005925
UDI-DI
06926802603505
Basic UDI-DI
69268026MD80B00001U7
Reference
MCC00201E
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
-
Authorised representative
R Sight B.V.
Last updated
31.07.2026 18:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Thromboplastin L

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
31.07.2026 08:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
sthemO CK Prest

sthemO CK Prest

IVD Class CIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450012231
Basic UDI-DI
3607450APTT0006RE
Reference
01223
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:10
Manufacturer productsView details
sthemO PT M

sthemO PT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450012187
Basic UDI-DI
360745099PT00057V
Reference
01218
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:10
Manufacturer productsView details
STA® - NeoPTimal 5

STA® - NeoPTimal

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450011630
Basic UDI-DI
360745099PT00037R
Reference
01163
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:10
Manufacturer productsView details
STA® - Néoplastine® CI Plus 5

STA® - Néoplastine® CI Plus

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450006063
Basic UDI-DI
360745099PT00017M
Reference
00606
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:10
Manufacturer productsView details
STA® - C.K. Prest®

STA® - C.K. Prest®

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450005974
Basic UDI-DI
3607450APTT0002R6
Reference
00597
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:10
Manufacturer productsView details
STA® - SPA +

STA® - SPA +

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Diagnostica Stago
Manufacturer SRN
FR-MF-000017089
UDI-DI
03607450003307
Basic UDI-DI
3607450OWPT00023N
Reference
00330
EMDN
W0103020101
EMDN description
PROTHROMBIN TIME ( QUICK TEST )
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:09
Manufacturer productsView details
Dade Actin FSL Activated PTT Reagent

IVDR_27_MAR EB_C_PROF_REAG_Actin_FSL

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN
DE-MF-000005039
UDI-DI
00842768003875
Basic UDI-DI
0405686900166V6
Reference
10445713
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Germany
Authorised representative
-
Last updated
30.07.2026 18:25
Manufacturer productsView details
Dade Actin FS Activated PTT Reagent

IVDR_27_MAR EB_C_PROF_REAG_Actin_FS

IVD Class CIVDR 2017/746On the marketProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN
DE-MF-000005039
UDI-DI
00842768003844
Basic UDI-DI
0405686900165V4
Reference
10445710
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Germany
Authorised representative
-
Last updated
30.07.2026 18:25
Manufacturer productsView details
Dade Actin Activated Cephaloplastin Reagent

IVDR_27_MAR EB_C_PROF_REAG_Actin

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN
DE-MF-000005039
UDI-DI
00842768003837
Basic UDI-DI
0405686900164V2
Reference
10445709
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Germany
Authorised representative
-
Last updated
30.07.2026 18:25
Manufacturer productsView details
06975237555026

R1:5*5ml R2:5*5ml

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
TAIZHOU STEELLEX BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000023056
UDI-DI
06975237555026
Basic UDI-DI
B-06975237555026
Reference
50201
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Romania
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
30.07.2026 06:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975237552025

R1:5*2ml R2:5*2ml

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
TAIZHOU STEELLEX BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000023056
UDI-DI
06975237552025
Basic UDI-DI
B-06975237552025
Reference
20201
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Romania
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
30.07.2026 06:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06975237550021

R1:5*10ml R2:5*10ml

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
TAIZHOU STEELLEX BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000023056
UDI-DI
06975237550021
Basic UDI-DI
B-06975237550021
Reference
100201
EMDN
W0103020102
EMDN description
ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country
Romania
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
30.07.2026 06:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details