← Back to catalogue
Vancomycin Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass C (EU MDR)
Ref P11405Model 25 tests
Identity
- Trade Name
- Vancomycin Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Vancomycin Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests EUDAMEDP11405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580521 EUDAMED
- Basic UDI-DI
- 697518250P1140568 EUDAMED
- Direct Marketing DI
- 06942293580521 EUDAMED
- EMDN Code
- W0102080319 VANCOMYCIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
New Device
Yes
EUDAMED
Vancomycin Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P1140568 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 231222d1-d77d-417a-9194-ccbbb6edbb06 61 fields · synced Oct 6, 2026