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Sterile Suction Irrigation Tubing Set with smoke evacuation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MSI305330
Identity
- Trade Name
- Suction Irrigation Set with Smoke Evacuation FDA UDI
- Generic Name
- Surgical irrigation tubing set, single-use FDA UDI
- Device Name
- Sterile Suction Irrigation Tubing Set with smoke evacuation EUDAMED
- Model / Reference
- MSI305330 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955797720027 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955797720027 EUDAMED
- 510(k) Number
- K141592 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical irrigation tubing set, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Denmark 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
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
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
Yes
FDA UDI
Sterile Suction Irrigation Tubing Set with smoke evacuation by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06955797720027 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 90c94f1e-8cfd-4778-9c5f-9886983158e5 61 fields · synced Jun 19, 2026
- FDA UDI 8aad6e0d-a698-40df-b4c4-5f33258241e4 33 fields · synced May 29, 2026