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Automated Digital Slide Scanning and Analysis System
EUDAMEDClass A (EU MDR)
Ref WK32Model DS-002, DS-005, DS-002P, DS-005P
Identity
- Device Name
- Automated Digital Slide Scanning and Analysis System EUDAMED
- Model / Reference
- DS-002, DS-005, DS-002P, DS-005P EUDAMEDWK32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289848763 EUDAMED
- Basic UDI-DI
- 69332898CE4486GL EUDAMED
- Direct Marketing DI
- 06933289848763 EUDAMED
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Automated Digital Slide Scanning and Analysis System by Guangzhou Wondfo 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 | 69332898CE4486GL | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 65ce3d20-45cd-4067-85a9-32c9c1aa0ee0 61 fields · synced Sep 30, 2026