Identity
- Trade Name
- Probe Cleanser EUDAMED
- Device Name
- Probe Cleanser EUDAMED
- Model / Reference
- 22008009 EUDAMED22003009 EUDAMED22005005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802808 EUDAMED06950334802785 EUDAMED06950334802563 EUDAMED
- Basic UDI-DI
- 69503348KTA006KZ EUDAMED69503348KTA004KV 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
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
No
EUDAMED
Probe Cleanser by Genrui Biotech Inc. — 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 | 69503348KTA006KZ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 0cc97306-593c-405c-a7af-ce8217a8d93f 61 fields · synced Jul 26, 2026
- EUDAMED 0a71c2a0-7c93-40b6-9f72-2ae953101ee2 61 fields · synced May 18, 2026
- EUDAMED 774597ed-2cb2-41b6-b1e5-3fac5c23976d 61 fields · synced May 18, 2026