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Suction Irrigation System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SAV-52Model SA SeriesRef SAV-32Ref SA-360CT-PRef SAV-36Ref SA-320CTRef SAV-32-ARef SA-450CT-PRef SI-0545P
Identity
- Trade Name
- Suction Irrigation System EUDAMEDLAGIS FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Suction Irrigation System EUDAMEDTrumpet Type Suction Irrigation Set for Dual Solution Bags with 32cm Probe, 280cm Tubing FDA UDI
- Model / Reference
- SA Series EUDAMEDSAV-52 EUDAMEDSAV-32 EUDAMEDSA-360CT-P EUDAMEDSAV-36 EUDAMEDSA-320CT EUDAMEDFDA UDISAV-32-A EUDAMEDSA-450CT-P EUDAMEDSI-0545P EUDAMED
- Description
- Trumpet Type Suction Irrigation Set for Dual Solution Bags with 32cm Probe, 280cm Tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04714123024268 EUDAMED04714123024237 EUDAMED04714123024442 EUDAMED04714123024251 EUDAMED04714123024183 EUDAMEDFDA UDI04714123024244 EUDAMED04714123024466 EUDAMED04714123024497 EUDAMED
- Basic UDI-DI
- 471412302SA-01TN EUDAMED
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Suction Irrigation System by Lagis Enterprise Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471412302SA-01TN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (9)
- EUDAMED 742d6263-d225-4baa-bbbb-cf9154133fea 61 fields · synced Sep 18, 2026
- EUDAMED 0ca681f0-6cac-4327-8ed4-cccfedb7b5c3 61 fields · synced May 17, 2026
- EUDAMED 11994db9-c3b7-40ff-b461-61af5690e74a 61 fields · synced May 18, 2026
- EUDAMED 9d466d52-eb60-4205-84e2-f90bc868ba06 61 fields · synced May 18, 2026
- EUDAMED 0bb16c36-7c1f-49cd-a1c4-245176a8f70c 61 fields · synced May 18, 2026
- EUDAMED 0f2f957c-ac4c-430e-8677-871329001750 61 fields · synced May 18, 2026
- EUDAMED 1b797026-5a5a-4647-9102-3d753342d682 61 fields · synced May 18, 2026
- EUDAMED 5a7cc8fb-5b6d-47a0-bcf4-2d1384ebbe9d 61 fields · synced May 19, 2026
- FDA UDI fb05aa9a-a295-43e8-9b91-fcae253fff83 34 fields · synced May 30, 2026