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Monopolar Laparoscopic Accessories
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref MPJ305330
Identity
- Trade Name
- Monopolar Laparoscopic Accessories EUDAMEDLaparoscopic Monopolar Electrode, J Hook FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Laparoscopic Monopolar Electrode, J Hook EUDAMED
- Model / Reference
- MPJ305330 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955797732020 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955797732020 EUDAMED
- 510(k) Number
- K142208 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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
Monopolar Laparoscopic Accessories by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06955797732020 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 37a7e29a-3ea6-4c73-980e-f3e4009f8f29 61 fields · synced Jun 19, 2026
- FDA UDI c817aea2-7d0f-4712-829a-4025f91d39a5 33 fields · synced May 30, 2026