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Cervical Cytology Image Processing Software
EUDAMEDClass A (EU MDR)
Ref Patholnsight-TModel PathoInsight-T
Identity
- Device Name
- Cervical Cytology Image Processing Software EUDAMED
- Model / Reference
- PathoInsight-T EUDAMEDPatholnsight-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976543600011 EUDAMED
- Basic UDI-DI
- 697654360Patholnsight-TVC EUDAMED
- EMDN Code
- W0202059092 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software 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
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Cervical Cytology Image Processing Software by Hangzhou PathoAl Technology 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 | 697654360Patholnsight-TVC | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou PathoAl Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000036338
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED 4224189e-c4ef-41a4-904e-fa97edef7e71 61 fields · synced Jul 22, 2026