Identity
- Trade Name
- Irrigation sleeve EUDAMED
- Device Name
- Irrigation Sleeve EUDAMED
- Model / Reference
- OSC40 EUDAMEDAT24NN84 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06930934747129 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
Irrigation sleeve by Beijing Sonicmed Technologies 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 | 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 018a35a3-b984-4be6-90de-7365936887e3 61 fields · synced Jul 24, 2026