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D-Q90100AFK

F-8Q1, F-8Q2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-Q90100AFK
Basic UDI-DI: B-Q90100AFK
Reference: /
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 15.07.2026 05:22

Manufacturer products Authorised representative products Authorised representative actors View details

MULTICALIBRATORE

FCC40-2-2

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: FUTURLAB S.R.L.
Manufacturer SRN: IT-MF-000046539
UDI-DI: D-MULTICALIBRATOREUG
Basic UDI-DI: B-MULTICALIBRATOREUG
Reference: FCC40-2-2
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:18

Manufacturer products View details

ClinChek® Urine Control, lyophil., for Nicotine and Metabolites, Level I, II, III

Urine Control for Nicotine and Metabolites

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS3083BF
Basic UDI-DI: B-MS3083BF
Reference: MS3083
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:15

Manufacturer products View details

ClinCal® Urine Calibrator Set, lyophil., for Nicotine and Metabolites (Level 0 - 6)

Urine Calibrator Set for Nicotine and Metabolites

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS3013AS
Basic UDI-DI: B-MS3013AS
Reference: MS3013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:15

Manufacturer products View details

ClinMass® Internal Standard for Nicotine and Metabolites

Internal Standard for Nicotine and Metabolites

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS3012AQ
Basic UDI-DI: B-MS3012AQ
Reference: MS3012
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

ClinMass® Internal Standard, lyophil., for Immunosuppressants (d₁₂-Cyclosporine A, ¹³Cd₂-Tacrolimus, ¹³Cd₃-Sirolimus, ¹³C₂d₄-Everolimus)

Internal Standard for Immunosuppressants (d₁₂-Cyclosporine A, ¹³Cd₂-Tacrolimus, ¹³Cd₃-Sirolimus, ¹³C₂d₄-Everolimus)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS1312AR
Basic UDI-DI: B-MS1312AR
Reference: MS1312
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

ClinMass® Internal Standard, lyophil., for Immunosuppressants (Cyclosporine D)

Internal Standard for Immunosuppressants (Cyclosporine D)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS1112AF
Basic UDI-DI: B-MS1112AF
Reference: MS1112
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

ClinMass® Internal Standard, lyophil., for Immunosuppressants (Ascomycin)

Internal Standard for Immunosuppressants (Ascomycin)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS1012AA
Basic UDI-DI: B-MS1012AA
Reference: MS1012
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:14

Manufacturer products View details

LIPIDIC CONTROL SET

FCC50-8-2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: FUTURLAB S.R.L.
Manufacturer SRN: IT-MF-000046539
UDI-DI: D-LIPIDIC-CONTROLQ2
Basic UDI-DI: B-LIPIDIC-CONTROLQ2
Reference: FCC50-8-2
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 03:49

Manufacturer products View details

D-K91201-094J

RQ-CRP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-094J
Basic UDI-DI: B-K91201-094J
Reference: /
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K91201-084G

RC-CRP1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-084G
Basic UDI-DI: B-K91201-084G
Reference: /
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Hemoglobin Standard

IS0255

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02559B
Basic UDI-DI: B-IS02559B
Reference: IS0255
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Lipoprotein A Standard

IS0247

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02479C
Basic UDI-DI: B-IS02479C
Reference: IS0247
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Immunoglobulin E Standard

IS0246

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02469A
Basic UDI-DI: B-IS02469A
Reference: IS0246
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Ferritin Standard

IS0245

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS024598
Basic UDI-DI: B-IS024598
Reference: IS0245
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Rheumatoid Factor Standard

IS0244

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS024496
Basic UDI-DI: B-IS024496
Reference: IS0244
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

C‐Reactive Protein HS

IS0243

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS024394
Basic UDI-DI: B-IS024394
Reference: IS0243
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

C‐Reactive Protein Standard

IS0242

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS024292
Basic UDI-DI: B-IS024292
Reference: IS0242
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

Antistreptolisin O

IS0241

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02418Y
Basic UDI-DI: B-IS02418Y
Reference: IS0241
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details

β‐2 Microglobulin 4 levels Standard

IS02297

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-IS02297NA
Basic UDI-DI: B-IS02297NA
Reference: IS02297
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:42

Manufacturer products View details