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Suction Irrigation System
EUDAMEDClass IIa (EU MDR)
Ref SI-0536PModel SA Series
Identity
- Trade Name
- Suction Irrigation System EUDAMED
- Device Name
- Suction Irrigation System EUDAMED
- Model / Reference
- SA Series EUDAMEDSI-0536P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123024480 EUDAMED
- Basic UDI-DI
- 471412302SA-01TN EUDAMED
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Suction Irrigation System by Lagis Enterprise 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 | 471412302SA-01TN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED dd5c19ff-854e-4767-89f3-97bc67d638f0 61 fields · synced Jun 19, 2026