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Fully Automated Pathology Staining System
EUDAMEDClass A (EU MDR)
Ref W948Model PA-3600
Identity
- Device Name
- Fully Automated Pathology Staining System EUDAMED
- Model / Reference
- PA-3600 EUDAMEDW948 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289828529 EUDAMED
- Basic UDI-DI
- 69332898CE2852G9 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Category: Microscope slide stainer IVD
Fully Automated Pathology Staining System by Guangzhou Wondfo Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69332898CE2852G9 | 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 dbec196b-4790-4d15-9af9-7ce7bc5b6600 61 fields · synced Jul 21, 2026