Identity
- Trade Name
- Probe Cleanser I EUDAMEDProbe Cleanser EUDAMED
- Device Name
- Hematology Reagent EUDAMED
- Model / Reference
- 3019102 EUDAMED3019108 EUDAMED3019927 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576743 EUDAMED06925794576750 EUDAMED06925794577795 EUDAMED
- Basic UDI-DI
- 69257945W0103010105R0LU EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMEDPoland EUDAMEDAustria 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 I by Dirui Industrial 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 | 69257945W0103010105R0LU | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 40c798b7-1b15-4065-9829-2739b990973e 61 fields · synced Jul 30, 2026
- EUDAMED 20cf49d1-49b5-4011-b10a-15cb42fc8f1e 61 fields · synced May 19, 2026
- EUDAMED 10d0c79d-f3fd-4259-b1cb-321fb86729d1 61 fields · synced Jul 14, 2026