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Cleanser
EUDAMEDClass A (EU MDR)
Ref 3013625Ref 3013633Ref 3013624Ref 3013635Ref 3002425 Ref 3013634Ref 3019906
Identity
- Trade Name
- Cleanser EUDAMED
- Device Name
- Hematology Reagent EUDAMED
- Model / Reference
- 3013625 EUDAMED3013633 EUDAMED3013624 EUDAMED3013635 EUDAMED3002425 EUDAMED3013634 EUDAMED3019906 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576781 EUDAMED06925794519276 EUDAMED06925794519283 EUDAMED06925794576767 EUDAMED06925794503046 EUDAMED06925794519290 EUDAMED06925794577702 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
- Poland 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
Cleanser 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 (7)
- EUDAMED b4c02e5a-3482-4c57-a9c8-99d896eb4831 61 fields · synced Jul 21, 2026
- EUDAMED 0b4f5173-5243-410a-b1d0-69e050c728ab 61 fields · synced May 17, 2026
- EUDAMED 6c2aff90-e826-4dad-9bf5-0aae42c3a2a2 61 fields · synced May 17, 2026
- EUDAMED c4ddf163-cebf-4453-9e4b-f18c8dc015fb 61 fields · synced May 18, 2026
- EUDAMED 05572de2-5e07-4413-b7a2-56d32437b030 61 fields · synced May 18, 2026
- EUDAMED 7d82f635-9087-40c2-822e-de69d7c84bc4 61 fields · synced May 18, 2026
- EUDAMED 0a33b171-c1c1-4e79-ad25-2bb96317e23e 61 fields · synced Jul 21, 2026