Identity
- Model / Reference
- uMammo 890i EUDAMED88000050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576833108 EUDAMED
- Basic UDI-DI
- 697157683310N6 EUDAMEDB-06971576833108 EUDAMED
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
88000050 by Shanghai United Imaging Healthcare Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697157683310N6 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683310N6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 0249c10d-d05a-4af1-87b8-ca794f069578 61 fields · synced Oct 6, 2026
- EUDAMED f587854c-5cbe-493e-9c0e-692ecf2c0cdc 61 fields · synced May 19, 2026