Shanghai Xodus Medical Company Limited
Registered establishment in Shanghai, China. 25 device types.
Shanghai Xodus Medical Company Limited is a specification developer holding a current FDA establishment registration. The registration covers Marker, Skin, Basin, Emesis and 23 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010380518 |
| FEI number | 3010380518 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No.376 Honglan Road; 2nd Floor; Building 2 |
| Postal code | 201411 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Protection Shield | 2020 | 439 |
| Anti Fog Solution And Accessories, Endoscopy | Class 2 | See Sharp, Trocar Swab | 2019 | 5 |
| Basin, Emesis | Class 1 | Emesis Bag | 2013 | 65 |
| Catheter And Tip, Suction | Class 2 | Suction Tips | 2013 | 70 |
| Component, Traction, Non-Invasive | Class 1 | Shoulder kit | 2013 | 18 |
| Container, Liquid Medication, Graduated | Class 1 | Cup | 2013 | 68 |
| Device, Transfer, Patient, Manual | Class 1 | Air Transfer Mattress, Blower Motor | 2023 | 76 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | ES Pencil and Tips, Grounding Pad | 2013 | 65 |
| Fiber, Medical, Absorbent | Class 1 | Absorbent Mat, Mop Heads | 2013 | 172 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Sponges | 2013 | 67 |
| Handle, Scalpel | Class 1 | Scalpel Handle | 2013 | 29 |
| Instrument, Manual, Surgical, General Use | Class 1 | Tray Corner Protector, Suture Bag, Nasotracheal Tube Immobilizer | 2013 | 110 |
| Kit, Surgical Instrument, Disposable | Class 1 | Room Turnover Kit | 2017 | 67 |
| Laparoscope, General & Plastic Surgery | Class 2 | See Sharp, Trocar Swab | 2019 | 46 |
| Light, Surgical, Accessories | Class 2 | Light Handle Cover | 2013 | 21 |
| Marker, Skin | Class 1 | Skin Marker | 2013 | 55 |
| Needle, Suturing, Disposable | Class 1 | Needle Counter, Plastic Cup, Plastic Box | 2013 | 21 |
| Non-Surgical Gown | Class 1 | Isolation Gown | 2020 | 318 |
| Operating Room Accessories Table Tray | Class 1 | Tray | 2013 | 25 |
| Support, Patient Position | Class 1 | Foam Positioning | 2013 | 66 |
| Syringe, Irrigating (Non Dental) | Class 1 | Syringe, Bulb Syringe, Asepto syringe | 2013 | 110 |
| System, Thermal Regulating | Class 2 | Hot Pink Pad Controller, Hot Pink Pad | 2026 | 8 |
| Tape And Bandage, Adhesive | Class 1 | Bandage | 2013 | 353 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Ruler | 2017 | 42 |
| Tray, Surgical, Instrument | Class 1 | Saf-T Pass, Transfer Zone, Plastic Holder | 2013 | 105 |
Clearances
No clearance names Shanghai Xodus Medical Company Limited as applicant. 5 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260903 | 2026-04-16 | DWJ | Traditional | Xodus Medical, Inc. |
| K182080 | 2018-09-19 | GCJ | Traditional | Xodus Medical, Inc. |
| K102372 | 2010-11-03 | GEI | Traditional | Jiangmen City Xinhui Baisheng Medical Equipment Co |
| K081647 | 2008-08-12 | GEI | Traditional | Xodus Medical, Inc. |
| K053321 | 2006-01-19 | FTA | Traditional | Xodus Medical, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Patient positioning products, Temperature management pads, Surgical positioning kits |
|---|---|
| Certifications | FDA 510K |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.