Newlink Biotech co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000045176
- Devices
- 1,337
- Registrations
- EUDAMED
Device · Authorizations
One Step Vaginal pH Rapid Test Ref C13-VPH01E5
IVD GeneralActive CE IVDD EUDAMED IVD GeneralHSV 1/2 IgG/IgM Rapid Test Ref L11-HSV01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMalaria P.f./P.v. Rapid Test Ref L11-MPV01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralHSV 1/2 IgG/IgM Rapid Test Ref L11-HSV02C3
IVD GeneralActive CE IVDD EUDAMED IVD GeneralClostridium difficile Toxin A/Toxin B Combo Assay Ref F11-CDT02C6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralBeta-Human Chorionic Gonadotropin (Beta-hCG) Assay Ref F11-BHCG01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralSARS-CoV-2 IgG/IgM Assay Ref F11-COV01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test (Urine) Ref L11-BZO01E1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralRespiratory Syncytial Virus (RSV) Assay Ref F11-RSV01C5
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test (Urine) Ref L11-OXY01B1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralNorovirus Control Ref L51-NO01PR
IVD GeneralActive CE IVDD EUDAMED IVD GeneralUric Acid Analyzer Ref C61-UAA100
Class AActive CE IVDR EUDAMED AChagas Rapid Test Ref L11-CHA01C3
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Shigella Sonnei Antigen Test Ref L11-SHS01F6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMyoglobin Control Ref L51-MYO01PR
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test - Carbamazepine (CBZ) (Urine) Ref L11-CBZ01C1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralAllergen-specific IgE Antibody Assay Ref WBIFIgE
IVD GeneralActive CE IVDD EUDAMED IVD GeneralThyroglobulin (TG) CLIA Test Ref G11-TG01A3
IVD GeneralActive CE IVDD EUDAMED IVD GeneralHemoglubin Analyzer Ref C21-HB100
Class AActive CE IVDR EUDAMED AMulti-Drug Rapid Test Key Cup (Urine) Ref L11-DUB08F1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test (Urine) Ref L11-DUA19E1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test (Urine) Ref L11-EDDP01B1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralAdenovirus pneumoniae and RSV Combo Assay Ref F11-AR01C5
IVD GeneralActive CE IVDD EUDAMED IVD Generalmyeloperoxidase (MPO) Assay Ref F11-MPO01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Dust Mite IgE Test Ref L11-DME01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralSalmonella typhi and paratyphi Antigen Combo Rapid Test Ref L11-STP02C6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test (Urine) Ref L11-DUA16C1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralAdenovirus&RSV Combo Rapid Test Ref L11-AR02C5
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test (Urine) Ref L11-DOA14E1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralRheumatoid Factor IgM Assay Ref F11-RFM01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralUrinalysis Analyzer Ref C21-UA100
Class AActive CE IVDR EUDAMED AOne Step Clostridium difficile GDH+ Toxin A +Toxin B Combo Test Ref L11-CD03F6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test (Urine) Ref L11-ACE01C1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralFood Allergen IgE Immunoblot Assay Ref W11-FIgE91B3
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step SARS-CoV-2 Antigen Test Ref L11-COV01B5
IVD GeneralActive CE IVDD EUDAMED IVD GeneralCA72-4 Assay Ref F11-CA72401C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralH-FABP and Myoglobin/CK-MB/Cardiac Troponin I Combo Rapid Test Ref L11-AMI02C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Single Drug Test (Urine) Ref L11-TCA01E1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test Cup (Oral Fluid) Ref L11-DOA02F8
IVD GeneralActive CE IVDD EUDAMED IVD GeneralStrep A Assay Ref F11-STA01C5
IVD GeneralActive CE IVDD EUDAMED IVD GeneralFerritin Assay Ref F11-FER01C4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step Astrovirus Test Ref L11-AS01F6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test 1-Step Cup (Urine) Ref L11-DOA14F1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralMulti-Drug Rapid Test 1-Step Cup (Urine) Ref L11-DOA07F1
IVD GeneralActive CE IVDD EUDAMED IVD GeneralTransferrin and FOB Combo Rapid Test Ref L11-TF01F6
IVD GeneralActive CE IVDD EUDAMED IVD GeneralSARS-CoV-2 Rapid Antigen Test (Oral Fluid) Ref L11-COV01C8
IVD GeneralActive CE IVDD EUDAMED IVD GeneralSARS-CoV-2 Antigen Control Ref L51-COV01PR
IVD GeneralActive CE IVDD EUDAMED IVD GeneralFluorescence lmmunoassay Control (hs-cTnT) Ref F51-SCTT
IVD GeneralActive CE IVDD EUDAMED IVD GeneralOne Step SARS-CoV-2 IgG/IgM Test Ref L11-COV01B4
IVD GeneralActive CE IVDD EUDAMED IVD GeneralCampylobacter Rapid Test Ref L11-CAM01C6
IVD GeneralActive CE IVDD EUDAMED IVD General
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Company details
- EUDAMED SRN
- CN-MF-000045176
- EU VAT number
- 91330100MA2H3RRH7M
- EUDAMED status
- Active
- EUDAMED registered name
- Newlink Biotech co., Ltd.
- Registered address
- No.24, No.24 Shuanglian Road, Haichang Street, Haining, No.24, Jiaxing, China
- Website
- www.kylinew.com
- [email protected]
- PRRC contact
- Zhang Ting(public in EUDAMED)