- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- D-GDCKM-402aOGVD
- Basic UDI-DI
- B-GDCKM-402aOGVD
- Reference
- GDCKM-402a
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 17.07.2026 07:02
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 18:27
Sync status
Successful
Device
2989865
Actor
47523
Certificate
3174
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
D-697994388Ir0823QEM
cTnI/CK-MB/Myo Test Panel
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- Manufacturer SRN
- CN-MF-000053775
- UDI-DI
- D-697994388Ir0823QEM
- Basic UDI-DI
- B-697994388Ir0823QEM
- Reference
- Ir082
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Crealkraft GmbH
- Last updated
- 17.07.2026 04:26
D-697994388Ir0813NEA
NT-proBNP N-Terminal Pro-B-Type Natriuretic Peptide Test Kit
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- Manufacturer SRN
- CN-MF-000053775
- UDI-DI
- D-697994388Ir0813NEA
- Basic UDI-DI
- B-697994388Ir0813NEA
- Reference
- Ir081
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Crealkraft GmbH
- Last updated
- 17.07.2026 04:25
D-697994388Ir0803LDZ
Myo Myoglobin Test Kit
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- Manufacturer SRN
- CN-MF-000053775
- UDI-DI
- D-697994388Ir0803LDZ
- Basic UDI-DI
- B-697994388Ir0803LDZ
- Reference
- Ir080
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Crealkraft GmbH
- Last updated
- 17.07.2026 04:25
D-697994388Ir07943DS
CK-MB Creatine Kinase-MB Test Kit
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- Manufacturer SRN
- CN-MF-000053775
- UDI-DI
- D-697994388Ir07943DS
- Basic UDI-DI
- B-697994388Ir07943DS
- Reference
- Ir079
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Crealkraft GmbH
- Last updated
- 17.07.2026 04:25
D-697994388Ir0783ZFW
cTnI Cardiac Troponin I Test Kit
IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Kangsheng Information Technology (Hangzhou) Co. LTD
- Manufacturer SRN
- CN-MF-000053775
- UDI-DI
- D-697994388Ir0783ZFW
- Basic UDI-DI
- B-697994388Ir0783ZFW
- Reference
- Ir078
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Crealkraft GmbH
- Last updated
- 17.07.2026 04:25
CK-MB Rapid Test
CK-MB Rapid Test
IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use
- Manufacturer
- Zhejiang Anji Saianfu Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000045029
- UDI-DI
- 69743840311624
- Basic UDI-DI
- B-69743840311624
- Reference
- 3050101
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- -
- Authorised representative
- Lotus NL B.V.
- Last updated
- 17.07.2026 04:12
Creatine Kinase-MB(CKMB) Rapid Test (Serum/Plasma)
Creatine Kinase-MB(CKMB) Rapid Test (Serum/Plasma)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- SAFECARE BIOTECH (HANGZHOU) CO., LTD.
- Manufacturer SRN
- CN-MF-000019109
- UDI-DI
- D-697424646CKMB002NTBF
- Basic UDI-DI
- B-697424646CKMB002NTBF
- Reference
- CKMB-3012
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- UnicareQ GmbH
- Last updated
- 17.07.2026 04:03
Creatine Kinase-MB(CKMB) Rapid Test (Whole Blood/Serum/Plasma)
Creatine Kinase-MB(CKMB) Rapid Test (Whole Blood/Serum/Plasma)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- SAFECARE BIOTECH (HANGZHOU) CO., LTD.
- Manufacturer SRN
- CN-MF-000019109
- UDI-DI
- D-697424646CKMB001NRB6
- Basic UDI-DI
- B-697424646CKMB001NRB6
- Reference
- CKMB-4012
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- UnicareQ GmbH
- Last updated
- 17.07.2026 04:03
MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma)
MB Isoenzyme of Creatine Kinase FIA Test (Serum/Plasma)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- SAFECARE BIOTECH (HANGZHOU) CO., LTD.
- Manufacturer SRN
- CN-MF-000019109
- UDI-DI
- D-697424646CKMB001FX8RT
- Basic UDI-DI
- B-697424646CKMB001FX8RT
- Reference
- CKMB-3012F
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- UnicareQ GmbH
- Last updated
- 17.07.2026 04:03
Creatine Kinase-MB Rapid Test (Whole Blood/Serum/Plasma)
Creatine Kinase-MB Rapid Test (Whole Blood/Serum/Plasma)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- SAFECARE BIOTECH (HANGZHOU) CO., LTD.
- Manufacturer SRN
- CN-MF-000019109
- UDI-DI
- D-697424646CKMB000NPAV
- Basic UDI-DI
- B-697424646CKMB000NPAV
- Reference
- CKMB-4012
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- Wellkang Ltd
- Last updated
- 17.07.2026 04:03
MB Isoenzyme of Creatine Kinase FIA Test (Whole blood/Serum/Plasma)
MB Isoenzyme of Creatine Kinase FIA Test (Whole blood/Serum/Plasma)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- SAFECARE BIOTECH (HANGZHOU) CO., LTD.
- Manufacturer SRN
- CN-MF-000019109
- UDI-DI
- D-697424646CKMB000FX5RE
- Basic UDI-DI
- B-697424646CKMB000FX5RE
- Reference
- CKMB-4012F
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- UnicareQ GmbH
- Last updated
- 17.07.2026 04:03
Creatine Kinase-MB Test (FIA)
Creatine Kinase-MB Test (FIA)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000001096
- UDI-DI
- D-5J01C1X8
- Basic UDI-DI
- B-5J01C1X8
- Reference
- 5J01C1-25-EU, 5J01C1-50-EU
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- MedPath GmbH
- Last updated
- 17.07.2026 03:06
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VID102J
- Basic UDI-DI
- B-VID102J
- Reference
- VID10-03-011
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:20
IVD generalNot specifiedOn the marketSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-50tDY
- Basic UDI-DI
- B-IVD83-02-50tDY
- Reference
- IVD83-02-50t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16
IVD generalNot specifiedOn the marketSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-30tDN
- Basic UDI-DI
- B-IVD83-02-30tDN
- Reference
- IVD83-02-30t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16
IVD generalNot specifiedOn the marketSingle useSterile
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-25tDY
- Basic UDI-DI
- B-IVD83-02-25tDY
- Reference
- IVD83-02-25t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16
IVD generalNot specifiedOn the marketSingle useSterile
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-20tDH
- Basic UDI-DI
- B-IVD83-02-20tDH
- Reference
- IVD83-02-20t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16
IVD generalNot specifiedOn the marketSingle use
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-10tDC
- Basic UDI-DI
- B-IVD83-02-10tDC
- Reference
- IVD83-02-10t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16
IVD generalNot specifiedOn the marketSingle useSterile
- Manufacturer
- Hangzhou Singclean Medical Products Co., Ltd.
- Manufacturer SRN
- CN-MF-000014098
- UDI-DI
- D-IVD83-02-100tAQ
- Basic UDI-DI
- B-IVD83-02-100tAQ
- Reference
- IVD83-02-100t
- EMDN
- W0102160701
- EMDN description
- CREATINE KINASE - MB MASS - RT & POC
- First on market country
- Germany
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 14.07.2026 02:16