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Sterile Suction Irrigation Tubing Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MSI305280
Identity
- Trade Name
- Sterile Suction Irrigation Tubing Set EUDAMEDSuction 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
- MSI305280 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955797720041 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955797720041 EUDAMED
- 510(k) Number
- K141592 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE 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
- Ireland 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 by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06955797720041 | Class IIa | Unknown |
| 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 996ce6d9-0faa-46f0-bfc2-dc9c4e530dd0 61 fields · synced Jun 18, 2026
- FDA UDI 84b9fb25-3506-44b3-8a06-1f5281db4e0a 33 fields · synced May 29, 2026