Identity
- Trade Name
- Ultrasonic Disposable Surgical Units EUDAMED
- Device Name
- Ultrasonic Disposable Surgical Units EUDAMED
- Model / Reference
- BE36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767872794 EUDAMED
- Basic UDI-DI
- 697176787BE36NC EUDAMED
- EMDN Code
- K020280 DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Ultrasonic Disposable Surgical Units by Wuxi Beien Surgery Device Co., Ltd. — Class IIb — 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 | 697176787BE36NC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 4f1716d3-8d28-42d2-8570-c15d0ad742ee 61 fields · synced Jun 18, 2026