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 Elite safety lancet 28G 1.8mm	05-212818	FDA UDI	Class II	Active
neoheel	1063T	FDA UDI	Class II	Active
SteriLance Impress Pro safety lancet 28G 1.8mm	05-192818	FDA UDI	Class II	Active
Viamed Surgical Blades	10#	FDA UDI	Class I	Active
iGlucose	05-113018	FDA UDI	Class II	Active
STERiLANCE OneStep Lancing Device	01-1930	FDA UDI	Class II	Active
SteriLance Elite safety lancet 26G 2.2mm	05-212622	FDA UDI	Class II	Active
neoheel	1061P	FDA UDI	Class II	Active
SteriLance Impress safety lancet 30G 1.5mm	05-173015	FDA UDI	Class II	Active
index Asurity	Index Asurity 3# SS 13#	FDA UDI	Class I	Active
Sterilance Press Safety Lancet 26G 1.8mm	05-052618	FDA UDI	Class II	Active
Sterilance soft twist lancet	01-0133	FDA UDI	Class II	Active
Sterilance soft twist lancet	01-0130	FDA UDI	Class II	Active
Sterilance SteriHeel Plus	30-101428	FDA UDI	Class II	Active
neoheel	1063T	FDA UDI	Class II	Active
SteriLance Impress safety lancet 26G 1.8mm	05-172618	FDA UDI	Class II	Active
SteriLance Impress safety lancet 21G 1.8mm	05-172118	FDA UDI	Class II	Active
STERiLANCE Soft Disposable Blood Lancet	01-0130	FDA UDI	Class II	Active
Surgical Blade Carbon Steel	60#	FDA UDI	Class I	Active
Press Disposable Safety Lancet	05-052118	FDA UDI	Class II	Active
Easydrip Insulin Penneedle	18-3105	FDA UDI	Class II	Active
SteriLance Elite safety lancet 21G 1.8mm	05-212118	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	25#	FDA UDI	Class I	Active
Sterilance Press Pressure Activated Safety Lancet	05-052618	FDA UDI	Class II	Active
STERiLANCE Elite Disposable Safety Lancet	05-211720B	FDA UDI	Class II	Active
Sterilance Press Plus	05-232618	FDA UDI	Class II	Active
index Asurity	Index Asurity 3# SS 15#	FDA UDI	Class I	Active
Sterilance Press2 Pressure Activated Safety Lancet	05-062818	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	23#	FDA UDI	Class I	Active
Sterilance Press2 Safety Lancet 26G 1.8mm	05-062618	FDA UDI	Class II	Active
Sterilance Press2 Pressure Activated Safety Lancet	05-063018	FDA UDI	Class II	Active
Transtek	"LDE4 02-2201"	FDA UDI	Class II	Active
STERiLANCE Press2 Disposable Safety Lancet	05-062620	FDA UDI	Class II	Active
index Asurity	Index Asurity 3# SS 11#	FDA UDI	Class I	Active
Sterilance Soft Twist Lancet	01-0128	FDA UDI	Class II	Active
Telli Health	01-0130	FDA UDI	Class II	Active
STERiLANCE Press2 Disposable Safety Lancet	05-062118	FDA UDI	Class II	Active
suttersync	soft 30G	FDA UDI	Class II	Active
SteriLance Elite safety lancet 17G 2.0mm	05-211720	FDA UDI	Class II	Active
SteriLance Impress Pro safety lancet 30G 1.5mm	05-193015	FDA UDI	Class II	Active
Disposable Safety Lancet Press2	05-062618	FDA UDI	Class II	Active
Easydrip Insulin Penneedle	18-3108	FDA UDI	Class II	Active
STERiLANCE Flex3 Disposable Safety Lancet	05-1521A	FDA UDI	Class II	Active
MiniCollect® PIXIE Heel Incision Safety Lancet	450526	FDA UDI	Class II	Unknown
Sterilance Press2 Pressure Activated Safety Lancet	05-062818	FDA UDI	Class II	Active
Sterilance Press Pressure Activated Safety Lancet	05-052818	FDA UDI	Class II	Active
Sterilance Press Pressure Activated Safety Lancet	05-052618	FDA UDI	Class II	Active
SteriLance Neoheel Heel Incision Safety Lancet	05-101025	FDA UDI	Class II	Active
SteriLance Softsense Lancet 30G	01-1930	FDA UDI	Class II	Active
SteriLance Impress safety lancet 28G 1.8mm	05-172818	FDA UDI	Class II	Active

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