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Bladder Scanner
EUDAMEDClass IIa (EU MDR)
Ref M1(with printer)Model M1Ref M1(without printer)Ref M1-W(without printer)Ref M2(with printer)Model M2Ref M2(without printer)Ref M1-W(with printer)Ref M4-HD(with printer)Model M4Ref M5
Identity
- Trade Name
- Bladder Scanner EUDAMED
- Device Name
- Bladder Scanner EUDAMED
- Model / Reference
- M1 EUDAMEDM1(with printer) EUDAMEDM1(without printer) EUDAMEDM1-W(without printer) EUDAMEDM2 EUDAMEDM2(with printer) EUDAMEDM2(without printer) EUDAMEDM1-W(with printer) EUDAMEDM4 EUDAMEDM4-HD(with printer) EUDAMEDM5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975124100063 EUDAMED06975124100056 EUDAMED06975124100131 EUDAMED06975124100223 EUDAMED06975124100216 EUDAMED06975124100148 EUDAMED06975124100629 EUDAMED06975124100780 EUDAMED
- Basic UDI-DI
- 697512410M1WT EUDAMED697512410M2WV EUDAMED697512410M4WZ EUDAMED697512410M5X3 EUDAMED
- Direct Marketing DI
- 06975124100063 EUDAMED06975124100056 EUDAMED06975124100131 EUDAMED06975124100223 EUDAMED06975124100216 EUDAMED06975124100148 EUDAMED06975124100629 EUDAMED06975124100780 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 | 697512410M1WT | 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 (8)
- EUDAMED 2d4514e2-06e8-4e4a-a58f-05fe7cb87beb 61 fields · synced Aug 2, 2026
- EUDAMED b4f03d62-fa72-41ee-9ab3-56c304be14f6 61 fields · synced May 17, 2026
- EUDAMED 75d2fe63-122e-496e-9460-badb68a59f80 61 fields · synced May 17, 2026
- EUDAMED ae3c3752-6f25-4321-8dca-42284ca525b7 61 fields · synced May 17, 2026
- EUDAMED d191717f-0cdc-4d8c-9824-6be53d6b7812 61 fields · synced May 17, 2026
- EUDAMED 2c31d3ce-ebc4-41ec-8f7d-6dbdb8a2f38d 61 fields · synced May 17, 2026
- EUDAMED 9b9c8fff-1be9-4cd2-8d9c-4db73e18c408 61 fields · synced May 18, 2026
- EUDAMED 1dba7661-5307-43a0-8750-905e6fabe1a1 61 fields · synced Jul 28, 2026