Sterilance Medical (Suzhou) Inc.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 8 device types, 98 products catalogued, 11 clearances.
Sterilance Medical (Suzhou) Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Blade, Scalpel, Handle, Scalpel and 6 other device types. 97 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2003.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3014649053 |
| FEI number | 3014649053 |
| DUNS | 554434897 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州施莱医疗器械有限公司 |
|---|---|
| Unified social credit code | 91320500753906536T |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | No.168 PuTuoShan Road |
| Postal code | 215153 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blade, Scalpel | Class 1 | Skin Graft Knife Blade, Blades, Gouge, Blade Arm Achilles, Standard SS, Stitch Cutter and 5 more | 2013 | 41 |
| Handle, Scalpel | Class 1 | Index Asurity, Safety Handle | 2014 | 29 |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | PressGo Lancing Device, LDE5 Lancing Device, EasyStep Lancing Device, LDE3 AST Lancing Device, LDE3 Lancing Device, NANOSense™ Lancing Device and 8 more | 2022 | 21 |
| Needle, Hypodermic, Single Lumen | Class 2 | Easydrip Disposable Insulin Needle | 2016 | 71 |
| Pack, Hot Or Cold, Reusable | Class 1 | ice bag | 2016 | 178 |
| Scalpel, One-Piece | Class 1 | Disposable Safety Scalpel, Mini Disposable Scalpel, Scalpel, Index handle, Safety Protected blade System, Standard Mini and 6 more | 2005 | 14 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Blueline™ Heel Incision Safety Lancets, SteriHeel Plus, Neoheel, SteriHeel, Safety-Heel®Newborn, OctaHeel and 33 more | 2003 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | Softsense, Onestep, Soft Pro, Softsure, Softsure Pro, NANOSense™ Lancets and 14 more | 2022 | 21 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K262631 | 2026-08-25 | QRK | Special | This company |
| K260122 | 2026-07-06 | QRL | Traditional | This company |
| K261634 | 2026-06-12 | QRK | Special | This company |
| K244036 | 2025-02-26 | FMK | Traditional | This company |
| K244031 | 2025-02-26 | QRK | Traditional | This company |
| K233796 | 2024-01-16 | FMK | Traditional | This company |
| K221521 | 2022-10-28 | FMK | Traditional | This company |
| K221507 | 2022-08-31 | QRK | Traditional | This company |
| K221970 | 2022-08-30 | QRL | Traditional | This company |
| K210745 | 2021-08-26 | FMK | Traditional | This company |
| K153706 | 2016-08-29 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | Safety lancets, Lancing devices, Blood sampling devices, Insulin pen needles, Surgical blades |
| Certifications | ISO13485, CGMP, CE (MDR), FDA 510(k) |
| Export markets | 50+ countries |
| 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.