Identity
- Device Name
- IHC Pathology Image Processing Software EUDAMED
- Model / Reference
- YC-P-222J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976543600028 EUDAMED
- Basic UDI-DI
- 697654360YC-P-222J7Y 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
IHC Pathology 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 | 697654360YC-P-222J7Y | 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 d62bc9cf-920c-4a87-af9b-882bf42cf898 61 fields · synced Jul 10, 2026