Identity
- Trade Name
- Bladder Scanner EUDAMED
- Device Name
- Bladder Scanner EUDAMED
- Model / Reference
- M4 EUDAMEDM4(without printer) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975124100551 EUDAMED
- Basic UDI-DI
- 697512410M4WZ EUDAMED
- Direct Marketing DI
- 06975124100551 EUDAMED
- EMDN Code
- Z12080304 ULTRASONIC BLADDER VOLUME SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Bladder Scanner by Suzhou Peaksonic Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697512410M4WZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Peaksonic Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038246
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED f361ba34-dff6-472c-8b0f-1c568aad5375 61 fields · synced May 23, 2026