Identity
- Trade Name
- Liquid-Based Cytology Slide Processor EUDAMED
- Device Name
- Liquid-Based Cytology Slide Processor EUDAMED
- Model / Reference
- ZP-2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973873149050 EUDAMED
- Basic UDI-DI
- 697387314ZPAXQ EUDAMED
- Direct Marketing DI
- 06973873149050 EUDAMED
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Liquid-Based Cytology Slide Processor by Hangzhou Dalton BioSciences, 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 | 697387314ZPAXQ | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Dalton BioSciences, Ltd.
- EUDAMED SRN
- CN-MF-000036196
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 81d435cb-3476-44ff-a40b-b3d34f6f7ebe 61 fields · synced Jul 26, 2026