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Electrosurgical Suction Irrigation System
EUDAMEDClass IIb (EU MDR)
Ref SIP-340-LModel SAP SeriesRef SAP-H
Identity
- Trade Name
- Electrosurgical Suction Irrigation System EUDAMED
- Device Name
- Electrosurgical Suction Irrigation System EUDAMED
- Model / Reference
- SAP Series EUDAMEDSIP-340-L EUDAMEDSAP-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123023216 EUDAMED04714123024527 EUDAMED
- Basic UDI-DI
- 471412302SAP-01UM EUDAMED
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010502 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Electrosurgical Suction Irrigation System by Lagis Enterprise 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 | 471412302SAP-01UM | Class IIb | 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 (2)
- EUDAMED f3fc7495-94ca-417a-b0fe-7deb31be7227 61 fields · synced Jul 23, 2026
- EUDAMED a6940cb3-7822-4165-9c01-61edd0c5d8d4 61 fields · synced May 18, 2026