Identity
- Trade Name
- Diff-Quik II EUDAMED
- Device Name
- Cytology EUDAMED
- Model / Reference
- DQX-09C EUDAMEDDQX-C10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889116899 EUDAMED04719889119579 EUDAMED
- Basic UDI-DI
- 471988911CytologyCR EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A 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
Diff-Quik II by BaSO 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 | 471988911CytologyCR | Class A | Active |
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Manufacturer
- Manufacturer
- BaSO Biotech Co., LTD..
- EUDAMED SRN
- TW-MF-000018809
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 529a84ab-be2e-4c52-a35f-b33fff8e3c0e 61 fields · synced Jul 29, 2026
- EUDAMED 276ecc98-17c7-4964-98e4-4367dc486f23 61 fields · synced May 17, 2026