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Sterile Suction Irrigation Tubing Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref MSI303280Ref MSI303200Ref MSI303330Ref MSI210330Ref MSI203280Ref MSI310450Ref MSI310330
Identity
- Trade Name
- Sterile Suction Irrigation Tubing Set EUDAMED
- Device Name
- Sterile Suction Irrigation Tubing Set with smoke evacuation EUDAMEDSterile Suction Irrigation Tubing Set EUDAMED
- Model / Reference
- MSI303280 EUDAMEDMSI303200 EUDAMEDMSI303330 EUDAMEDMSI210330 EUDAMEDMSI203280 EUDAMEDMSI310450 EUDAMEDMSI310330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955797720348 EUDAMED06955797720324 EUDAMED06955797720522 EUDAMED06955797720089 EUDAMED06955797720331 EUDAMED06955797720126 EUDAMED06955797720119 EUDAMED
- Basic UDI-DI
- B-06955797720348 EUDAMEDB-06955797720324 EUDAMEDB-06955797720522 EUDAMEDB-06955797720089 EUDAMEDB-06955797720331 EUDAMEDB-06955797720126 EUDAMEDB-06955797720119 EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Suction Irrigation Tubing Set by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141592 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06955797720348 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimicro Medical Systems (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000014590
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (8)
- EUDAMED b6891751-0c5e-4e7d-8e13-153f10fbf001 61 fields · synced Oct 1, 2026
- EUDAMED 6dec9578-9967-451d-93d8-0cacc4ab1803 61 fields · synced May 16, 2026
- EUDAMED d6c05175-9543-4d40-814d-9ecf22f2214d 61 fields · synced May 17, 2026
- EUDAMED 731183cf-aff1-41cf-b4ae-5df9ca78559c 61 fields · synced May 18, 2026
- EUDAMED bf9524de-2ab0-4f40-b20c-f9595fb8f3c1 61 fields · synced May 18, 2026
- EUDAMED 9cb401bc-97f0-4b9e-94d2-20442c876023 61 fields · synced May 19, 2026
- EUDAMED 0f2b9062-8f30-486a-b8ba-1656be580597 61 fields · synced May 19, 2026
- FDA 510(k) K141592 1 fields · synced May 18, 2026