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TREN

Last updated

01.08.2026 13:11

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Device

2989326

Actor

47520

Certificate

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Active filter:EMDN:W0201069080

19 device results listed.

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CSVXML
06925912711056

I-UNICELL

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN
CN-MF-000001137
UDI-DI
06925912711056
Basic UDI-DI
692591270146HE
Reference
I6101
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Cyprus
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
31.07.2026 18:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
QC Cassette

QC Cassette

IVD Class AIVDR 2017/746On the market
Manufacturer
Biohit Oyj
Manufacturer SRN
FI-MF-000014642
UDI-DI
06419587350004
Basic UDI-DI
6419587QC0010PV
Reference
740470
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Finland
Authorised representative
-
Last updated
31.07.2026 17:36
Manufacturer productsView details
KETOSURE POC

KETOSURE POC base unit

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testing
Manufacturer
Apex Biotechnology Corp.
Manufacturer SRN
TW-MF-000019773
UDI-DI
04713648764581
Basic UDI-DI
47136487607B00KBUa79
Reference
M033
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
31.07.2026 06:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BLOTrix System 5/ BLOTrix Reader C1 L

BLOTrix System 5

IVD Class AIVDR 2017/746On the market
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270607
Basic UDI-DI
42604972700022MW
Reference
b55btrc1l
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 02:02
Manufacturer productsView details
04260497270553

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270553
Basic UDI-DI
42604972700021MU
Reference
b4c4btrc1
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 02:02
Manufacturer productsView details
JAEGER mobile Reader

mB2

IVD Class AIVDR 2017/746On the market
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270225
Basic UDI-DI
42604972700005MW
Reference
JmR-mB2
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
31.07.2026 02:02
Manufacturer productsView details
NIOX

NIOX Breathing Handle

IVD Class BIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testing
Manufacturer
NIOX AB
Manufacturer SRN
SE-MF-000010044
UDI-DI
07350047030175
Basic UDI-DI
735004703NIOXHANDLE6R
Reference
12-1010
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Sweden
Authorised representative
-
Last updated
16.07.2026 11:37
Manufacturer productsView details
ProciseDx Calibration Cartridge

4759

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testing
Manufacturer
ProciseDx Inc.
Manufacturer SRN
US-MF-000040747
UDI-DI
08100322947594
Basic UDI-DI
081003229PDXB475922V8
Reference
4759
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
France
Authorised representative
QbD RepS BV
Last updated
16.07.2026 03:33
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
QuickCheck

MBSQCR100

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing
Manufacturer
MicroBioSensor Ltd
Manufacturer SRN
GB-MF-000021594
UDI-DI
D-MBSQCR100MS
Basic UDI-DI
B-MBSQCR100MS
Reference
MBSQCR100
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Netherlands
Authorised representative
QNET B.V.
Last updated
14.07.2026 04:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Lactate Pro 2 (LT-1730)

Lactate Pro 2 (LT-1730)

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing
Manufacturer
ARKRAY Factory, Inc.
Manufacturer SRN
JP-MF-000003008
UDI-DI
D-48303H7
Basic UDI-DI
B-48303H7
Reference
48303
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
ARKRAY Europe, B.V.
Last updated
11.07.2026 20:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Lactate Pro 2 (LT-1730)

Lactate Pro 2 (LT-1730)

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing
Manufacturer
ARKRAY Factory, Inc.
Manufacturer SRN
JP-MF-000003008
UDI-DI
D-48302H5
Basic UDI-DI
B-48302H5
Reference
48302
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Lithuania
Authorised representative
ARKRAY Europe, B.V.
Last updated
11.07.2026 20:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
KETOSURE POC

KETOSURE POC base unit

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing
Manufacturer
Apex Biotechnology Corp.
Manufacturer SRN
TW-MF-000019773
UDI-DI
D-47136487609BU94
Basic UDI-DI
B-47136487609BU94
Reference
S5400044
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
11.07.2026 19:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HELIC ABT Suction pump

HELIC ABT Suction pump

IVD generalIVDDOn the marketNear-patient testingProfessional testing
Manufacturer
«Association of Medicine and Analytics» Company Limited
Manufacturer SRN
RU-MF-000036645
UDI-DI
D-4680008050108VFEQ
Basic UDI-DI
B-4680008050108VFEQ
Reference
0108
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Finland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
11.07.2026 19:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
HELIC ABT Reader

HELIC ABT Reader

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testing
Manufacturer
«Association of Medicine and Analytics» Company Limited
Manufacturer SRN
RU-MF-000036645
UDI-DI
14680008050219
Basic UDI-DI
4680008050100UX
Reference
0105
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Finland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
02.07.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AMA RUT Reader

AMA RUT Reader

IVD Class AIVDR 2017/746On the marketProfessional testing
Manufacturer
«Association of Medicine and Analytics» Company Limited
Manufacturer SRN
RU-MF-000036645
UDI-DI
14680008050103
Basic UDI-DI
4680008050200V4
Reference
0204
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Finland
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
02.07.2026 00:08
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
BLOTrix System 5/ BLOTrix Reader R2 L

-

IVD Class ANot specifiedOn the market
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270614
Basic UDI-DI
42604972700022MW
Reference
b55btrr2l
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 02:00
Manufacturer productsView details
BLOTrix System 5/ BLOTrix Reader S1

-

IVD Class ANot specifiedOn the market
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270621
Basic UDI-DI
42604972700022MW
Reference
b55btrs1
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 02:00
Manufacturer productsView details
recomScan System 5/ BLOTrix Reader S1

-

IVD Class ANot specifiedOn the market
Manufacturer
BioSciTec GmbH
Manufacturer SRN
DE-MF-000007888
UDI-DI
04260497270638
Basic UDI-DI
42604972700022MW
Reference
rs55btrs1
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Germany
Authorised representative
-
Last updated
01.07.2026 02:00
Manufacturer productsView details
QC Cassette

-

IVD Class ANot specifiedOn the market
Manufacturer
Biohit Oyj
Manufacturer SRN
FI-MF-000014642
UDI-DI
06419587351001
Basic UDI-DI
6419587QC0010PV
Reference
740480
EMDN
W0201069080
EMDN description
VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country
Finland
Authorised representative
-
Last updated
24.06.2026 17:36
Manufacturer productsView details