Identity
- Device Name
- Wash Buffer（10×） EUDAMED
- Model / Reference
- 1L，10L EUDAMEDMS001102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976964666238 EUDAMED
- Basic UDI-DI
- 697696466MS0010001BB EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Wash Buffer（10×） by Hunan AccuBio Biotech 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 | 697696466MS0010001BB | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan AccuBio Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041914
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 88607698-1841-41a4-9646-2be83224ad58 61 fields · synced Jul 25, 2026