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 SteriHeel Plus Heel Incision Safety Lancet	30-106514	FDA UDI	Class II	Active
STERiLANCE Elite Disposable Safety Lancet	05-212620	FDA UDI	Class II	Active
Perfect Lancets Lancetas	01-0130	FDA UDI	Class II	Active
Soft	01-0128	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	12#	FDA UDI	Class I	Active
Sterilance Lite3	05-112818	FDA UDI	Class II	Active
Sterilance Press Plus Safety Lancet 30G 1.5mm	05-233015	FDA UDI	Class II	Active
Sterilance Soft Lancet 33G	01-0133	FDA UDI	Class II	Active
Soft Twist Lancets	01-0132	FDA UDI	Class II	Active
Sterilance Press Pressure Activated Safety Lancet	05-052618	FDA UDI	Class II	Active
STERiLANCE Elite Disposable Safety Lancet	05-213015	FDA UDI	Class II	Active
Viamed Surgical Blades	21#	FDA UDI	Class I	Active
neoheel	1060M	FDA UDI	Class II	Active
Soft	01-0128	FDA UDI	Class II	Active
SteriLance OneStep	02-2401	FDA UDI	Class II	Active
STERILANCE Soft Disposable Blood Lancet	01-0128	FDA UDI	Class II	Active
SteriLance Elite Pro safety lancet 23G	05-2923A	FDA UDI	Class II	Active
Sterilance	01-0121	FDA UDI	Class II	Active
STERiLANCE Elite Disposable Safety Lancet	05-212118	FDA UDI	Class II	Active
Sterilance Press4 Pressure Activated Safety Lancet	05-081720B	FDA UDI	Class II	Active
SteriLance Softsense Lancet 33G	01-1933	FDA UDI	Class II	Active
STERiLANCE Press2 Disposable Safety Lancet	05-062812	FDA UDI	Class II	Active
Surgical Blade	10-0170	FDA UDI	Class I	Active
Sterilance Press Safety Lancet 30G 1.5mm	05-053015	FDA UDI	Class II	Active
Sterilance Press2 Pressure Activated Safety Lancet	05-062618	FDA UDI	Class II	Active
Sterilance Soft Lancet 28G	01-0128	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	11#	FDA UDI	Class I	Active
Carbon Steel Surgical Blade	24#	FDA UDI	Class I	Active
STERiLANCE Elite Disposable Safety Lancet	05-212118	FDA UDI	Class II	Active
Viamed Surgical Blades	15C	FDA UDI	Class I	Active
STERiLANCE LDE4 Lancing Device	02-2201	FDA UDI	Class II	Active
Sterilance	02-2201	FDA UDI	Class II	Active
Sterilance Press Pressure Activated Safety Lancet	05-052818	FDA UDI	Class II	Active
EXALANCE LDE4 Lancing Device	02-2201	FDA UDI	Class II	Active
STERiLANCE Press2 Disposable Safety Lancet	05-062122	FDA UDI	Class II	Active
Sterilance Press2 Disposable Safety Lancet	05-062818	FDA UDI	Class II	Active
Sterilance Press2 Safety Lancet 30G 1.5mm	05-063015	FDA UDI	Class II	Active
Carbon Steel Surgical Blade	21#	FDA UDI	Class I	Active
Sterilance Press Plus Safety Lancet 26G 1.8mm	05-232618	FDA UDI	Class II	Active
STERiLANCE Elite Pro Disposable Safety Lancet	05-2923A	FDA UDI	Class II	Active
Sterilance Press2 Pius Disposable Safety Lancet	05-242818	FDA UDI	Class II	Active
Sterilance Soft Lancet 26G	01-0126	FDA UDI	Class III	Active
Transtek	"LDE4 02-2201"	FDA UDI	Class II	Active
Sterilance Lite3	05-112618	FDA UDI	Class II	Active
SteriLance Neoheel Heel Incision Safety Lancet	05-106514	FDA UDI	Class II	Active
STERiLANCE Elite Pro Disposable Safety Lancet	05-2921A	FDA UDI	Class II	Active
STERILANCE Lite 3 30G 1.8mm	05-113018	FDA UDI	Class II	Active
Sterilance SteriHeel Plus Heel Incision Safety Lancet	30-108575	FDA UDI	Class II	Active
Gluco Perfect Lancets Lancetas	01-0130	FDA UDI	Class II	Active
Sterilance Press Safety Lancet 28G 1.8mm	05-052818	FDA UDI	Class II	Active

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