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79 device results listed.

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00816467020136

FastPack Control Kit International

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020136
Basic UDI-DI: B-00816467020136
Reference: 25000065
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Color Compensation kit

PN-501

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719326750972
Basic UDI-DI: 87193267509PN-501EV
Reference: PN-501
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

2SMARTFinder Color Compensation

PFCC-2S

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327116173
Basic UDI-DI: 87193271161PFCC-2SKV
Reference: PFCC-2S
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

RealAccurate® Quadruplex Color Compensation v5

PFCC-Rv5

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327497975
Basic UDI-DI: 87193274979PFCC-Rv5QR
Reference: PFCC-Rv5
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

PathoNostics Color Calibration kit

PN-507

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: PathoNostics B.V.
Manufacturer SRN: NL-MF-000002705
UDI-DI: 08719327498026
Basic UDI-DI: 87193274980PN-507GC
Reference: PN-507
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

Control IV for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230333
Basic UDI-DI: 1912013223A371-081WE
Reference: A371-081
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

Control set – Level I – III for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230265
Basic UDI-DI: 1912013223A371-012VT
Reference: A371-012
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

Clinical Chemical Quality Control Serum

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261572
Basic UDI-DI: B-06942202261572
Reference: 232030415202
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

Low: Dissolved liquid: 4mL×5bottles，Freeze-dried powder: 0.18g×5bottles