Identity
- Trade Name
- Irrigation sleeve EUDAMED
- Device Name
- Irrigation Sleeve EUDAMED
- Model / Reference
- OSC40 EUDAMEDOS8SFL81 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930934744203 EUDAMED
- Basic UDI-DI
- 693093472b043G7 EUDAMED
- EMDN Code
- Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Ultrasonic surgical system generator
Irrigation sleeve by Beijing Sonicmed Technologies Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 693093472b043G7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Sonicmed Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000021987
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED be5868af-6827-416e-848e-84a20278fead 61 fields · synced Jul 19, 2026