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Breast Immunohistochemistry Image Processing Software
EUDAMEDClass A (EU MDR)
Ref NAModel SenseCare-Breast IHC
Identity
- Trade Name
- Breast Immunohistochemistry Image Processing Software EUDAMED
- Device Name
- Breast Immunohistochemistry Image Processing Software EUDAMED
- Model / Reference
- SenseCare-Breast IHC EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973065280240 EUDAMED
- Basic UDI-DI
- 697306528024JL EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Breast Immunohistochemistry Image Processing Software by Shanghai Sensetime Intelligent Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697306528024JL | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai Sensetime Intelligent Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039203
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7c3e4723-868a-48fc-8e4d-d24b788b5800 61 fields · synced Jul 11, 2026