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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

22.09.2026 11:56

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Device

3537119

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47728

Certificate

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Active filter:EMDN:W01021608

141 device results listed.

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biotical Calprotectin Positive control (30u)

biotical Calprotectin Positive control (30u) / 30 controles positivos Calprotectin (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942143256
Basic UDI-DI
B-84365942143256
Reference
CPRT30CP
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:02
Manufacturer productsView details
biotical Transferrin Positive control

biotical Transferrin Positive control (1u) / 1 control positivo Transferrin (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942142570
Basic UDI-DI
B-84365942142570
Reference
CPRT01TF
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:02
Manufacturer productsView details
biotical Transferrin Positive control

biotical Transferrin Positive control (30u) / 30 controles positivos Transferrin (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942142402
Basic UDI-DI
B-84365942142402
Reference
CPRT30TF
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:02
Manufacturer productsView details
biotical FOB Positive Control (1u)

biotical FOB Positive Control (1u) / 1 control positivo FOB (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942142020
Basic UDI-DI
B-84365942142020
Reference
CPRT01F
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:01
Manufacturer productsView details
biotical FOB Positive Control (30u)

biotical FOB Positive Control (30u) / 30 controles positivos FOB (sin test rápido)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use
Manufacturer
BIOTICAL HEALTH S.L.U
Manufacturer SRN
ES-MF-000018831
UDI-DI
84365942141962
Basic UDI-DI
B-84365942141962
Reference
CNRT30
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Spain
Authorised representative
-
Last updated
12.07.2026 10:01
Manufacturer productsView details
mLabs® Multi-level CRP Controls

M101-091025

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166513
Basic UDI-DI
B-06974703166513
Reference
M101-091025
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level NT-proBNP Controls

M101-091013

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166469
Basic UDI-DI
B-06974703166469
Reference
M101-091013
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level Cardiac Panel 3 Controls

M101-091012

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166452
Basic UDI-DI
B-06974703166452
Reference
M101-091012
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level PCT Controls

M101-091009

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166445
Basic UDI-DI
B-06974703166445
Reference
M101-091009
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level BNP Controls

M101-091008

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166438
Basic UDI-DI
B-06974703166438
Reference
M101-091008
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level TnI Controls

M101-091007

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166421
Basic UDI-DI
B-06974703166421
Reference
M101-091007
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
mLabs® Multi-level D-Dimer Controls

M101-091002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703166414
Basic UDI-DI
B-06974703166414
Reference
M101-091002
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Romania
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
qLabs® PT-INR Test Strips

QS-1-24

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703160221
Basic UDI-DI
B-06974703160221
Reference
QS-1-24
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
qLabs® PT-INR Test Strips

QS-1-12

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703160214
Basic UDI-DI
B-06974703160214
Reference
QS-1-12
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
qLabs® PT-INR Test Strips

QS-1-48 Pro

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703160153
Basic UDI-DI
B-06974703160153
Reference
QS-1-48 Pro
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
qLabs® PT-INR Test Strips

QS-1-24 Pro

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN
CN-MF-000007991
UDI-DI
06974703160146
Basic UDI-DI
B-06974703160146
Reference
QS-1-24 Pro
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Germany
Authorised representative
Obelis s.a.
Last updated
06.07.2026 20:28
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CK-MB Control

CK-MB Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000024149
UDI-DI
06974521001096
Basic UDI-DI
B-06974521001096
Reference
QC104
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Ireland
Authorised representative
QbD RepS BV
Last updated
06.07.2026 19:29
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
abioSCOPE Control

abioSCOPE Control

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagent
Manufacturer
Abionic SA
Manufacturer SRN
CH-MF-000026307
UDI-DI
07649996894106
Basic UDI-DI
7649996894P02A1NL
Reference
P02.00045
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Greece
Authorised representative
Veranex Germany GmbH
Last updated
03.07.2026 06:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
QuikRead go CRP Control High

-

IVD generalNot specifiedOn the market
Manufacturer
Aidian Oy
Manufacturer SRN
FI-MF-000023611
UDI-DI
06438115001492
Basic UDI-DI
B-06438115001492
Reference
153763
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Finland
Authorised representative
-
Last updated
23.06.2026 11:07
Manufacturer productsView details
QuikRead go iFOBT Control Quantitative

-

IVD generalNot specifiedOn the market
Manufacturer
Aidian Oy
Manufacturer SRN
FI-MF-000023611
UDI-DI
06438115001348
Basic UDI-DI
B-06438115001348
Reference
152390
EMDN
W0102160801
EMDN description
CONTROLS IMMUNOCHEM - RT & POC
First on market country
Finland
Authorised representative
-
Last updated
23.06.2026 11:07
Manufacturer productsView details