Identity
- Trade Name
- Bladder Volume Tester EUDAMED
- Device Name
- Bladder Volume Tester EUDAMED
- Model / Reference
- BVT01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BVT01YV EUDAMED
- Basic UDI-DI
- B-BVT01YV EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bladder Volume Tester by Xuzhou Kaixin Electronic Instrument Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-BVT01YV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xuzhou Kaixin Electronic Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000040932
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 61a4588c-a45d-46b8-966a-b0e4f5426a78 61 fields · synced Oct 7, 2026