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Single Use Suction and Irrigation System
EUDAMEDClass IIa (EU MDR)
Ref SIS332TModel SIS328
Identity
- Device Name
- Single Use Suction and Irrigation System EUDAMED
- Model / Reference
- SIS328 EUDAMEDSIS332T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971062272435 EUDAMED
- Basic UDI-DI
- 697106227SISQY EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Single Use Suction and Irrigation System by Suzhou Lantex Medical Technology Company Limited — Class IIa — MDR — listed in EUDAMED
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 | 697106227SISQY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Lantex Medical Technology Company Limited
- EUDAMED SRN
- CN-MF-000039444
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED aa5e6b57-fd97-466b-b761-8eb18174ab09 61 fields · synced Jun 19, 2026