Covidien Medical Products (Shanghai) Manufacturing LLC

Registration Details

Registration Name: Covidien Medical Products (Shanghai) Manufacturing LLC
Registration Number: 3006451981
FEI Number: 3006451981
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Building #10, 1st Floor of Building #6, 2nd Floor of Building #15, 789 Puxing Road, 201114, Peoples Republic of China
City: Shanghai
Country: CN

Regulatory Submissions

510(k) Number: K113572

Owner / Operator

Firm Name: Covidien llc
Operator Number: 1282497
Address: 15 HAMPSHIRE STREET, --
City: Mansfield
State: MA
Postal Code: 02048
Country: US

US Agent

Business Name: COVIDIEN
Contact Name: Dawn Tindall
Address: 200 Medtronic Dr
City: Lafayette
State: CO
ZIP: 80026
Country: US
Email: [email protected]
Phone: 303 5817034

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrosurgical, Cutting & Coagulation & Accessories	GEI	Class 2	General, Plastic Surgery	No	2014-01-23
System, Ablation, Microwave And Accessories	NEY	Class 2	General, Plastic Surgery	No	2017-01-12
Catheter, Percutaneous	DQY	Class 2	Cardiovascular	No	2025-03-10
Staple, Implantable	GDW	Class 2	General, Plastic Surgery	No	1997-12-04
Irrigator, Sinus	KAR	Class 1	Ear, Nose, Throat	No	2018-09-13
Catheter, Percutaneous, Neurovasculature	QJP	Class 2	Cardiovascular	No	2025-03-10
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	POL	Class 2	Neurology	No	2025-03-10
Catheter, Thrombus Retriever	NRY	Class 2	Cardiovascular	No	2025-03-10

Proprietary Names

LigaSure Curved, Small Jaw, Open Sealer/Divider Force EZ Emprint" Reinforced Long Percutaneous Antenna with Thermosphere" Technology, CA30L2 Emprint" Reinforced Short Percutaneous Antenna with Thermosphere" Technology, CA15L2 Emprint" Reinforced Standard Percutaneous Antenna with Thermosphere" Technology, CA20L2 Valleylab LS10, LS Series Single Channel Vessel Sealing Generator, VLLS10GEN LigaSure Curved Jaw Open Reusable Clamp LigaSure Curved Jaw Open Sealer/Divider Electrode Force FX Force FX Electrosurgical Generator 8CS, Force FX-8CS Force FX Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS Force FX Electrosurgical Generator 8C, Force FX-8C LigaSure Dolphin Tip Laparoscopic Sealer/Divider, LS1500 LigaSure Tissue Fusion Electrode Straight Jaw, LS2071 Ligasure Tissue Fusion Electrode Curved Jaw, LS3112 LigaSure Atlas Tissue Fusion Laparoscopic Instrument, LS1037 LigaSure Tissue Fusion Electrode Angled Jaw, LS2111 LigaSure Vessel Sealing System, LigaSure 8 LigaSure Atlas Tissue Fusion Open Instrument, LS1020 LigaSure Dolphin Tip Laparoscopic Sealer/Divider LigaSure Dolphin Tip Open Sealer/Divider, LS1520 Ligasure Tissue Fusion Electrode Curved Jaw, LS3092 React 68 Catheter Auto Suture 1960100, HydroCleanse Sinus Wash Delivery System React 71 Catheter Navien Intracranial Support Catheter Lectrovac, Valleylab Models Valleylab Suction Coagulator, E2608-6 LigaSure Curved, Small jaw Open Sealer/Divider, LF1212A LigaSure¿ Impact LigaSure¿ V Solitaire X Emprint Microwave Ablation System- CAMSYS Footswitch- RFASW; & Remote Temperature Probe- RTP20 Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1 LigaSure¿ Atlas ATLAS Suction Coagulators Valleylab Suction Coagulator Valleylab Suction Coagulator, E3305 Valleylab Suction Coagulator, E3310 and E3310NSB

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)