Identity
- Trade Name
- Probe Cleaning Solution EUDAMED
- Device Name
- Probe Cleaning Solution EUDAMED
- Model / Reference
- 32107002 EUDAMED32001048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334814436 EUDAMED06950334821366 EUDAMED
- Basic UDI-DI
- 69503348PAA003FB EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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 Cleaning Solution 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 | 69503348PAA003FB | 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 (2)
- EUDAMED 591f728a-0b54-4e46-b7d7-acc3c78b8889 61 fields · synced Jul 23, 2026
- EUDAMED 43ee1f61-af38-498b-83cf-e6647e2399cb 61 fields · synced May 18, 2026