← Back to catalogue
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Immunonephelom…
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×30 mL, R2: 1×20 mL Ref DB0301Model 2×50 test/box Calibrator:0.5mL×2
Identity
- Trade Name
- Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Immunonephelometric Method) EUDAMEDAnti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- R1: 2×30 mL, R2: 1×20 mL EUDAMED2×50 test/box Calibrator:0.5mL×2 EUDAMEDDB0301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300599 EUDAMED06970522641101 EUDAMED
- Basic UDI-DI
- B-06937287300599 EUDAMEDB-06970522641101 EUDAMED
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody Assay Kit (Immunonephelom… by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06937287300599 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 05d38bb4-6ff9-4849-891f-5c673a44a00a 61 fields · synced Oct 6, 2026
- EUDAMED 05d38bb4-6ff9-4849-891f-5c673a44a00a-1 61 fields · synced Jun 10, 2026
- EUDAMED 05d38bb4-6ff9-4849-891f-5c673a44a00a-2 61 fields · synced Jun 10, 2026
- EUDAMED 3dfaab34-1aa3-4d9b-88f4-2244be2fcc7e 61 fields · synced Jul 10, 2026