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C-Peptide Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013763Model 2×50 tests/kitRef 3013845Model 1×50 tests/kit
Identity
- Trade Name
- C-Peptide Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- C-Peptide Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/kit EUDAMED3013763 EUDAMED1×50 tests/kit EUDAMED3013845 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202224010 EUDAMED06925794519764 EUDAMED
- Basic UDI-DI
- B-06942202224010 EUDAMEDB-06925794519764 EUDAMED
- EMDN Code
- W0102060101 C-PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
C-Peptide Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202224010 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 759ab76c-865c-4d98-b7a4-3da2111903ff 61 fields · synced Jun 20, 2026
- EUDAMED 9a8ed3da-c126-414c-989d-e5db4c49b021 61 fields · synced May 19, 2026