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TREN

Last updated

01.08.2026 18:27

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Device

2989852

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Certificate

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Active filter:EMDN:W0201010105

79 device results listed.

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Merilyzer AutoQuant 200 Excelus

FAACNQ-05

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Meril Diagnostics Pvt. Ltd.
Manufacturer SRN
IN-MF-000028158
UDI-DI
08905459002426
Basic UDI-DI
8905459FABA75
Reference
FAAAQ2-04
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Bulgaria
Authorised representative
Obelis s.a.
Last updated
01.08.2026 00:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06944904018676
Basic UDI-DI
69449040SHYQ-BA20******KG
Reference
BS-200
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053033855
Basic UDI-DI
69449040SHYQ-BA24******ML
Reference
ES 300
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053033671
Basic UDI-DI
69449040SHYQ-BA36******P9
Reference
Mispa Nano Plus
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053033664
Basic UDI-DI
69449040SHYQ-BA23******M3
Reference
Spin200E
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN
CN-MF-000014156
UDI-DI
06903053033657
Basic UDI-DI
69449040SHYQ-BA10******JV
Reference
Spin120
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 19:57
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06925912734451

iBC 900-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912734451
Basic UDI-DI
692591270282HP
Reference
BC0204
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:36
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
RX daytona plus (with ISE)

RX daytona plus

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing
Manufacturer
Randox Laboratories Limited
Manufacturer SRN
XI-MF-000028410
UDI-DI
05055273207774
Basic UDI-DI
50552732ADAYPLU015HS
Reference
RX4040
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Northern Ireland
Authorised representative
-
Last updated
31.07.2026 08:11
Manufacturer productsView details
RX imola

RX imola

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing
Manufacturer
Randox Laboratories Limited
Manufacturer SRN
XI-MF-000028410
UDI-DI
05055273206104
Basic UDI-DI
50552732ARXIMOL025WX
Reference
RX4900
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Northern Ireland
Authorised representative
-
Last updated
31.07.2026 08:11
Manufacturer productsView details
SpotChem D-Concept 2e (SD-4840)

SpotChem D-Concept 2e (SD-4840)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
ARKRAY Factory, Inc.
Manufacturer SRN
JP-MF-000003008
UDI-DI
04987486047216
Basic UDI-DI
4987486BC0110046F9
Reference
110046
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Ireland
Authorised representative
ARKRAY Europe, B.V.
Last updated
31.07.2026 07:34
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AA01

AA01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Otsuka Electronics Co., Ltd.
Manufacturer SRN
JP-MF-000001943
UDI-DI
04987274142079
Basic UDI-DI
4987274W0201010101A01EW
Reference
04987274142079
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Netherlands
Authorised representative
Emergo Europe B.V.
Last updated
31.07.2026 07:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NS-Prime

NS-Prime

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
Otsuka Electronics Co., Ltd.
Manufacturer SRN
JP-MF-000001943
UDI-DI
04987274142093
Basic UDI-DI
4987274W0201010101PRMN2
Reference
04987274142093
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Italy
Authorised representative
Emergo Europe B.V.
Last updated
31.07.2026 07:32
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Selectra ProM

6003-404

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
VitalScientific B.V.
Manufacturer SRN
NL-MF-000021018
UDI-DI
03701700860396
Basic UDI-DI
37017008ProM-SeriesSL
Reference
6003-435
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Netherlands
Authorised representative
-
Last updated
30.07.2026 21:52
Manufacturer productsView details
Selectra ProS

6003-500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
VitalScientific B.V.
Manufacturer SRN
NL-MF-000021018
UDI-DI
03701700860327
Basic UDI-DI
37017008ProS-SeriesW6
Reference
6003-500
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Netherlands
Authorised representative
-
Last updated
30.07.2026 21:52
Manufacturer productsView details
Pentra C200 ISE

Pentra C200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
HORIBA ABX SAS
Manufacturer SRN
FR-MF-000000320
UDI-DI
03610230006672
Basic UDI-DI
361023pentra_c2006U
Reference
1280090002
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
France
Authorised representative
-
Last updated
30.07.2026 21:15
Manufacturer productsView details
CA-310

Clinical Chemistry Analyzer CA-310 with ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Furuno Electric Co., Ltd.
Manufacturer SRN
JP-MF-000026828
UDI-DI
04560161906901
Basic UDI-DI
0456016CA-310-ISEMZ
Reference
CA000002750
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Ireland
Authorised representative
MedEnvoy Global BV
Last updated
30.07.2026 18:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CA-400

Clinical Chemistry Analyzer CA-400 with ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Furuno Electric Co., Ltd.
Manufacturer SRN
JP-MF-000026828
UDI-DI
04560161906840
Basic UDI-DI
0456016CA-400-ISEN5
Reference
CA000001475
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Ireland
Authorised representative
MedEnvoy Global BV
Last updated
30.07.2026 18:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CA-270

Clinical Chemistry Analyzer CA-270 with ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Furuno Electric Co., Ltd.
Manufacturer SRN
JP-MF-000026828
UDI-DI
04560161906826
Basic UDI-DI
0456016CA-270-ISEPW
Reference
CA000001474
EMDN
W0201010105
EMDN description
CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country
Ireland
Authorised representative
MedEnvoy Global BV
Last updated
30.07.2026 18:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details