Identity
- Trade Name
- Chemiluminescent Wash Solution EUDAMED
- Device Name
- Chemiluminescent Wash Solution EUDAMED
- Model / Reference
- 0 .5L×1 EUDAMEDXY005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293591077 EUDAMED
- Basic UDI-DI
- 697518250XY005N6 EUDAMED
- Direct Marketing DI
- 06942293591077 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Chemiluminescent Wash Solution by Beijing Diagreat Biotechnologies Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697518250XY005N6 | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED f09774a0-69b3-43b3-9de4-05a589d3ad9c 61 fields · synced Jun 19, 2026