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Monopolar Laparoscopic Accessories

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref MPS305330

by Unimicro Medical Systems (Shenzhen) Co., Ltd

Identity

Trade Name
Monopolar Laparoscopic Accessories EUDAMED
Laparoscopic Monopolar Electrode, Spatula Hook FDA UDI
Generic Name
Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
Laparoscopic Monopolar Electrode, Spatula Hook EUDAMED
Model / Reference
MPS305330 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06955797732037 EUDAMEDFDA UDI
Basic UDI-DI
B-06955797732037 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 EUDAMED
Class 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 — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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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 (3)

  • EUDAMED 50d2c106-91dc-4229-94c4-872161c7a993 61 fields · synced Jun 19, 2026
  • FDA UDI 7711036e-5631-4f44-941f-f185a13db50e 33 fields · synced May 30, 2026
  • FDA 510(k) K142208 1 fields · synced May 18, 2026