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Sign in to claim this brandSterilance Medical (Suzhou) Inc.
US
Last updated May 30, 2026
Part of Sterilance Medical (Suzhou) Inc.
What Sterilance Medical (Suzhou) Inc. makes
The company manufactures single-use and reusable manual blood lancing devices, including safety lancets and reusable lancing systems, as well as single-use blood lancets and autoinjector needles. It also produces single-use surgical blades and scalpel handles, designed for medical and diabetic care applications.
The portfolio includes devices classified as Class I, Class II, and Class III under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sterilance Medical (Suzhou) Inc. manufacture?
Sterilance Medical (Suzhou) Inc. specializes in devices primarily used for medical and diabetic care. Their portfolio includes single-use and reusable manual blood lancing devices, such as safety lancets and reusable lancing systems, as well as single-use blood lancets and autoinjector needles. They also produce single-use surgical blades and reusable scalpel handles, covering a range of applications from diabetes management to surgical procedures.
Where is Sterilance Medical (Suzhou) Inc. based?
The company is headquartered in the United States. While the name includes 'Suzhou,' this appears to be part of the company’s formal designation rather than indicating a primary location outside the US.
Which regulatory registries list Sterilance Medical’s devices?
Sterilance Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices that have undergone regulatory processes, ensuring traceability and compliance with US requirements.
How are Sterilance Medical’s devices classified under regulatory frameworks?
The company’s devices fall into three regulatory classes: Class I (generally low-risk devices like reusable scalpel handles), Class II (moderate-risk devices such as some blood lancets or autoinjector needles), and Class III (higher-risk devices like certain reusable lancing systems or specialized lancets). Classification depends on factors like intended use, risk to the patient, and regulatory standards.
Why do some of Sterilance Medical’s devices require higher regulatory classification?
Higher classifications like Class II or Class III are assigned to devices that pose greater risks to patients or require more stringent validation to ensure safety and effectiveness. For example, reusable lancing systems or autoinjector needles may fall into these categories due to their repeated use, potential for infection, or critical role in patient care, necessitating additional scrutiny during regulatory review.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 554434897
Catalogue (189)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| index Asurity | Index Asurity 4# SS 22# | FDA UDI | Class I | Active |
| Carbon Steel Surgical Blade | 20# | FDA UDI | Class I | Active |
| Sterilance Press Pressure Activated Safety Lancet | 05-052818 | FDA UDI | Class II | Active |
| Sterilance LDE3 With AST Cap | 02-1903 | FDA UDI | Class II | Active |
| neoheel | 1062N | FDA UDI | Class II | Active |
| Sterilance SteriHeel Plus Heel Incision Safety Lancet | 30-101428 | FDA UDI | Class II | Active |
| Sterilance Press Plus | 05-232818 | FDA UDI | Class II | Active |
| STERiLANCE Elite Disposable Safety Lancet | 05-212818 | FDA UDI | Class II | Active |
| STERiLANCE Elite Disposable Safety Lancet | 05-212812 | FDA UDI | Class II | Active |
| Carbon Steel Surgical Blade | 15# | FDA UDI | Class I | Active |
| neoheel | 1060M | FDA UDI | Class II | Active |
| STERiLANCE Press2 Disposable Safety Lancet | 05-062122 | FDA UDI | Class II | Active |
| SteriLance Impress Pro safety lancet 26G 1.8mm | 05-192618 | FDA UDI | Class II | Active |
| Sterilance Flex3 Depth Adjustable Safety Lancet | 05-1526A | FDA UDI | Class II | Active |
| index Asurity | Index Asurity 4# SS 23# | FDA UDI | Class I | Active |
| Carbon Steel Surgical Blade | 16# | FDA UDI | Class I | Active |
| Sterilance Press4 Pressure Activated Safety Lancet | 05-082818 | FDA UDI | Class II | Active |
| Sterilance Press2 Pius Disposable Safety Lancet | 05-243018 | FDA UDI | Class II | Active |
| STERiLANCE | Soft 28G | FDA UDI | Class II | Active |
| SteriLance Impress Pro safety lancet 21G 2.2mm | 05-192122 | FDA UDI | Class II | Active |
| STERiLANCE Impress Pro Disposable Safety Lancet | 05-192818 | FDA UDI | Class II | Active |
| MiniCollect® PIXIE Heel Incision Safety Lancet | 450525 | FDA UDI | Class II | Unknown |
| Viamed Surgical Blades | 11# | FDA UDI | Class I | Active |
| SteriLance Elite safety lancet 30G 1.5mm | 05-213015 | FDA UDI | Class II | Active |
| Sterilance SteriHeel Plus Heel Incision Safety Lancet | 30-101025 | FDA UDI | Class II | Active |
| Sterilance Press Plus Safety Lancet 28G 1.8mm | 05-232818 | FDA UDI | Class II | Active |
| sutter sync | LDE4 | FDA UDI | Class II | Active |
| neoheel | 1061P | FDA UDI | Class II | Active |
| index Asurity | Index Asurity 3# SS 10# | FDA UDI | Class I | Active |
| Soft | 01-0130 | FDA UDI | Class II | Active |
| Sterilance Press Pressure Activated Safety Lancet | 05-052318 | FDA UDI | Class II | Active |
| Sterilance Press2 Disposable Safety Lancet | 05-063018 | FDA UDI | Class II | Active |
| SteriLance Softsense Lancet 28G | 01-1928 | FDA UDI | Class II | Active |
| STERiLANCE Press2 Disposable Safety Lancet | 05-063018 | FDA UDI | Class II | Active |
| Carbon Steel Surgical Blade | 22# | FDA UDI | Class I | Active |
| STERiLANCE Elite Pro Disposable Safety Lancet | 05-2926A | FDA UDI | Class II | Active |
| STERiLANCE | Soft 28G | FDA UDI | Class II | Active |
| Sterilance Press2 Pressure Activated Safety Lancet | 05-062818 | FDA UDI | Class II | Active |
| MiniCollect® PIXIE Heel Incision Safety Lancet | 450527 | FDA UDI | Class II | Unknown |
| Transtek | Soft 30G 01-0130 | FDA UDI | Class II | Active |
| Sterile Blood Lancet | SHN02GM0123-50 | FDA UDI | Class II | Active |
| Sterilance Press | 05-052818 | FDA UDI | Class II | Active |
| STERiLANCE SteriHeel Plus Heel Incision Safety Lancet | 30-106514 | FDA UDI | Class II | Active |
| Soft | 01-0130 | FDA UDI | Class II | Active |
| Sterilance LDE3 | 02-1903 | FDA UDI | Class II | Active |
| index Asurity | Index Asurity 4# | FDA UDI | Class I | Active |
| SteriLance Lancing Device Model LDE 4-AST | 02-2201 | FDA UDI | Class II | Active |
| SteriIance Soft Twist Lancets | 01-0130 | FDA UDI | Class II | Active |
| Sterilance Lite 3 Button Activated Safety Lancet | 05-112818 | FDA UDI | Class II | Active |
| Index Asurity Disposable Safety Scalpel | 22-0422 | FDA UDI | Class I | Active |
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