Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 5L, 2.5L EUDAMED32021005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334821380 EUDAMED
- Basic UDI-DI
- 69503348PAA006FH EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Bulgaria 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
Sample Diluent 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 | 69503348PAA006FH | Class A | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8322238d-b01b-4237-b8df-2f71ce4f519e 61 fields · synced Jun 19, 2026