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Electrosurgical Suction Irrigation System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref SAP-HTModel SAP Series
Identity
- Trade Name
- Electrosurgical Suction Irrigation System EUDAMED
- Device Name
- Electrosurgical Suction Irrigation System EUDAMED
- Model / Reference
- SAP Series EUDAMEDSAP-HT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123024510 EUDAMED
- Basic UDI-DI
- 471412302SAP-01UM EUDAMED
- EMDN Code
- K0201010502 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243867 | Class IIb | Active |
| 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 ae6396b0-ee01-4b09-82d5-db25baebf878 61 fields · synced Jun 18, 2026
- FDA 510(k) K243867 1 fields · synced May 18, 2026