Bladder Scanner
by Suzhou Peaksonic Medical Technology Co., Ltd. United States EUDAMED
Ref M5
EMDN Z12080304
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697512410M5X3 | Date12 Feb 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- M5
- Primary DI / UDI-DI
- 06975124100780
- Basic UDI-DI
- 697512410M5X3
- Direct Marketing DI
- 06975124100780
- EMDN Code
- Z12080304 Ultrasonic bladder volume scanners
- Device Class
- Class IIa
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000038246
- Authorised representative
- Kingsmead Service B.V. NL-AR-000002066
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1dba7661-5307-43a0-8750-905e6fabe1a1