Question 1

What types of medical devices does Sterilance Medical (Suzhou) Inc. manufacture?

Accepted Answer

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.

Question 2

Where is Sterilance Medical (Suzhou) Inc. based?

Accepted Answer

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.

Question 3

Which regulatory registries list Sterilance Medical’s devices?

Accepted Answer

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.

Question 4

How are Sterilance Medical’s devices classified under regulatory frameworks?

Accepted Answer

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.

Question 5

Why do some of Sterilance Medical’s devices require higher regulatory classification?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Sterilance Flex3 Depth Adjustable Safety Lancet	05-1523A	FDA UDI	Class II	Active
Sterilance Press4 Pressure Activated Safety Lancet	05-082118	FDA UDI	Class II	Active
SteriLance Neoheel Heel Incision Safety Lancet	05-102030	FDA UDI	Class II	Active
SteriLance Elite Pro safety lancet 28G	05-2928A	FDA UDI	Class II	Active
Transtek	Soft 30G 01-0130	FDA UDI	Class II	Active
Viamed Surgical Blades	15#	FDA UDI	Class I	Active
STERiLANCE Elite Disposable Safety Lancet	05-213012	FDA UDI	Class II	Active
SteriLance Elite Pro safety lancet 26G	05-2926A	FDA UDI	Class II	Active
Sterilance Press2 Safety Lancet 28G 1.8mm	05-062818	FDA UDI	Class II	Active
STERiLANCE Soft Disposable Blood Lancet	01-0133 33G	FDA UDI	Class II	Active
Viamed Surgical Blades	22#	FDA UDI	Class I	Active
SteriLance Impress Pro safety lancet 21G 1.8mm	05-192118	FDA UDI	Class II	Active
index Asurity	Index Asurity 3#	FDA UDI	Class I	Active
Sterilance Soft Disposable Blood Lancet	01-0128	FDA UDI	Class II	Active
Viamed Surgical Blades	12#	FDA UDI	Class I	Active
STERiLANCE Elite Disposable Safety Lancet	05-212618	FDA UDI	Class II	Active
SteriLance Impress safety lancet 21G 2.2mm	05-172122	FDA UDI	Class II	Active
Viamed Surgical Blades	24#	FDA UDI	Class I	Active
STERiLANCE OneStep Lancing Device	02-2401	FDA UDI	Class II	Active
Sterilance Press Pressure Activated Safety Lancet	05-052128	FDA UDI	Class II	Active
Surgical Blade	10-0115C	FDA UDI	Class I	Active
Sterilance Flex3 Depth Adjustable Safety Lancet	05-1523A	FDA UDI	Class II	Active
Sterilance	01-0123	FDA UDI	Class II	Active
STERiLANCE Press2 Disposable Safety Lancet	05-063012	FDA UDI	Class II	Active
neoheel	1062N	FDA UDI	Class II	Active
Smartmeter	LDE4	FDA UDI	Class II	Active
Sterilance Flex3 Depth Adjustable Safety Lancet	05-1528A	FDA UDI	Class II	Active
Sterilance Flex3 Depth Adjustable Safety Lancet	05-1526A	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	10#	FDA UDI	Class I	Active
Sterilance Press4 Pressure Activated Safety Lancet	05-083015	FDA UDI	Class II	Active
UltraLANCE	05-232618	FDA UDI	Class II	Active
Bard	RM0752754	FDA UDI	Class I	Active
STERiLANCE Elite Pro Disposable Safety Lancet	05-2928A	FDA UDI	Class II	Active
Viamed Surgical Blades	20#	FDA UDI	Class I	Active
Disposable Pen Needles	3205	FDA UDI	Class II	Active
Bard	22-0311B	FDA UDI	Class I	Active
Viamed Surgical Blades	23#	FDA UDI	Class I	Active
Sterilance Press2 Pressure Activated Safety Lancet	05-062618	FDA UDI	Class II	Active
SteriLance Elite Pro safety lancet 21G	05-2921A	FDA UDI	Class II	Active

Sterilance Medical (Suzhou) Inc.

What Sterilance Medical (Suzhou) Inc. makes

Frequently asked questions

Information

Catalogue (189)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities