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Ultrasonic Disposable Surgical Units
EUDAMEDClass IIb (EU MDR)
Ref MARS36Ref UNITSModel BE14Ref MCY23Ref BE45Ref MARS20Ref MCY36
Identity
- Trade Name
- Ultrasonic Disposable Surgical Units EUDAMED
- Device Name
- Ultrasonic Disposable Surgical Units EUDAMED
- Model / Reference
- MARS36 EUDAMEDBE14 EUDAMEDUNITS EUDAMEDMCY23 EUDAMEDBE45 EUDAMEDMARS20 EUDAMEDMCY36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767872824 EUDAMED06971767872770 EUDAMED06971767873135 EUDAMED06971767872800 EUDAMED06971767872817 EUDAMED06971767873142 EUDAMED
- Basic UDI-DI
- 697176787MARS36WN EUDAMED697176787UNITS37 EUDAMED697176787MCY23TE EUDAMED697176787BE45ND EUDAMED697176787MARS20W7 EUDAMED697176787MCY36TP 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 | 697176787MARS36WN | 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 (6)
- EUDAMED 9e84d2a9-c182-4f47-9d6d-9d506f733340 61 fields · synced Sep 17, 2026
- EUDAMED e2e75116-6e41-4987-aea8-5445dcb48a55 61 fields · synced May 17, 2026
- EUDAMED 2c2d8592-d14a-470a-a1a1-0f72cad823bb 61 fields · synced May 17, 2026
- EUDAMED bc10562a-7312-4069-903a-3926acef8b4e 61 fields · synced May 17, 2026
- EUDAMED 3ec8d4ec-b63d-4988-b3aa-cb7708baa579 61 fields · synced May 17, 2026
- EUDAMED b65c5da1-3d75-495e-8de0-370d7fb0c9b9 61 fields · synced May 18, 2026