Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010380518

FEI Number

3010380518

Entity Name

Shanghai Xodus Medical Company Limited

City/State/Country

Shanghai, CN

Establishment Address

No.376 Honglan Road; 2nd Floor; Building 2, Hongmiao Industrial Zone; Fengxian District, Shanghai 201411, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xodus Medical Shanghai (Owner Number: 10043833)

Owner / Operator Contact Address

No. 376 Honglan Rd. 2nd Floor Building 2, Hongmiao Industrial Zone, Fengxian Dist, Shanghai, CN-SH 201411, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation Gown Skin Marker Foam Positioning Hot Pink Pad Controller Hot Pink Pad Scalpel Handle Sponges Grounding Pad Ruler Emesis Bag Absorbent Mat, Mop Heads Syringe, Bulb Syringe, Asepto syringe See Sharp, Trocar Swab Suction Tips Bandage Air Transfer Mattress, Blower Motor Tray Face Protection Shield Light Handle Cover Needle Counter, Plastic Cup, Plastic Box Cup ES Pencil and Tips Tray Corner Protector, Suture Bag, Nasotracheal Tube Immobilizer Room Turnover Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-10
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2013-03-27
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-03-27
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2026-04-21
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-03-27
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2013-03-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-02-04
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2017-11-04
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2013-03-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2013-03-27
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-03-27
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-10-28
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2019-10-28
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2013-03-27
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-03-27
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2023-02-22
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2013-03-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-10
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2013-03-27
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-03-27
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2013-03-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-03-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-03-27
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2017-11-02

Official Correspondent

Chen Ye

US Agent Details

Paul Lloyd Business: Xodus Medical Email: plloyd@xodusmedical.com Phone: (724) 3375500

Related Public Records

Same Entity

Xodus Medical Shanghai

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010380518. Last updated year: 2026. Please use registration number 3010380518 when referencing this establishment in official correspondence.