Question 1

What types of medical devices does ZIEN Medical Technologies manufacture?

Accepted Answer

ZIEN Medical Technologies produces a range of medical devices primarily used in interventional and procedural settings. Their portfolio includes single-use general-purpose syringes, thrombectomy suction catheters, and vascular guide-catheters. They also manufacture thrombectomy tubing sets (non-electronic), vascular microcatheters, basic peripheral angioplasty balloon catheters, reusable urine flowmeters, and single-use scalpels. These devices are designed for applications like vascular interventions, thrombectomy procedures, and general surgical use.

Question 2

Where is ZIEN Medical Technologies based, and how does this affect its devices?

Accepted Answer

ZIEN Medical Technologies is based in the United States, which means its devices are subject to U.S. medical device regulations, including FDA oversight. The company’s products are designed and manufactured in compliance with these regulations, ensuring they meet the necessary safety, performance, and labeling requirements for the U.S. market. This also influences how the devices are classified and registered, such as through the FDA’s UDI database.

Question 3

Which regulatory registries list ZIEN Medical Technologies’ devices?

Accepted Answer

ZIEN Medical Technologies’ devices are listed in two key regulatory registries: the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry. These listings help ensure transparency and traceability of the devices in both the U.S. and European markets, allowing healthcare providers, regulators, and other stakeholders to verify product details and compliance status.

Question 4

How are ZIEN Medical Technologies’ devices classified under FDA regulations?

Accepted Answer

ZIEN Medical Technologies’ devices are classified under three FDA categories: Class I, Class II, and Class IIa. The classification depends on the device’s risk level and intended use. For example, general-purpose syringes and single-use scalpels are typically Class I, while more complex devices like thrombectomy suction catheters or vascular guide-catheters may fall under Class II or Class IIa due to their higher risk and regulatory controls. This classification determines the regulatory pathway and requirements for each device.

Question 5

Are ZIEN Medical Technologies’ devices used in both single-use and reusable applications?

Accepted Answer

Yes, ZIEN Medical Technologies manufactures devices for both single-use and reusable applications. Most of their products, such as syringes, thrombectomy catheters, and scalpels, are designed for single-use to ensure patient safety and sterility. However, they also produce reusable devices like urine flowmeters, which are intended for repeated use in clinical settings with proper cleaning and sterilization protocols.

Device	Model / Reference	Registries	Class	Status
SAM IO ® Needle - 45mm	IO807	EUDAMED	Class IIa	Active
XableCath	XC-035-090A	FDA UDI	Class II	Unknown
Control 11F Mechanical Thrombectomy System	A11-090	FDA UDI	Class II	Active
XableCath	XC-018-090A	FDA UDI	Class II	Unknown
Stream Dx	SDX02	FDA UDI	Class II	Active
XO Cross 35	C35-090-H	FDA UDI	Class II	Active
Landmark Catheter Introducer Kit	LR-KIT	FDA UDI	Class II	Active
XO Score	S6.25-065	FDA UDI	Class II	Active
PenBlade Safety Scalpel	#10 Blade	FDA UDI	Class I	Active
PowrSyringe	PWR-10	FDA UDI	Class II	Unknown
Control 7F Mechanical Thrombectomy System	A7-090	FDA UDI	Class II	Active
XO Cross 14	C14-135-H	FDA UDI	Class II	Active
PenBlade Safety Scalpel	#11P Blade	FDA UDI	Class I	Active
XableCath	XC-035-145A	FDA UDI	Class II	Unknown
Control 7F Mechanical Thrombectomy System	A7-060	FDA UDI	Class II	Active
XO Cross 14	C14-175	FDA UDI	Class II	Unknown
XO Cath	E20-130-S	FDA UDI	Class II	Active
Control 7F Mechanical Thrombectomy System	ASP-1033	FDA UDI	Class II	Active
XO Cross 35	C35-135-H	FDA UDI	Class II	Active
XableCath	XC-014-145B	FDA UDI	Class II	Unknown
Cats	CATS-D	FDA UDI	Class II	Active
XableCath	XC-014-090B	FDA UDI	Class II	Unknown
The Morgan Lens Ocular Irrigation Convenience Kit	MT2063	FDA UDI	Class I	Active
XO Cross 14	C14-090	FDA UDI	Class II	Unknown
XableCath	XC-014-090A	FDA UDI	Class II	Unknown
XO Cross 14	C14-175-H	FDA UDI	Class II	Active
XO Cross 14	C14-135	FDA UDI	Class II	Unknown
Aspire Max 6 Aspiration Catheter 55cm	A6-055	FDA UDI	Class II	Unknown
XO Cross 35	C35-175-H	FDA UDI	Class II	Active
XO Cross 35	C35-135	FDA UDI	Class II	Unknown
XableCath	XC-014-065B	FDA UDI	Class II	Unknown
Control 11F Mechanical Thrombectomy System	ASP-1036	FDA UDI	Class II	Active
XableCath	XC-035-145B	FDA UDI	Class II	Unknown
XO Cath	E20-130-B	FDA UDI	Class II	Active
Control 7F Mechanical Thrombectomy System	ASP-1013	FDA UDI	Class II	Active
Control 10T Mechanical Thrombectomy Filter	ASP-1039	FDA UDI	Class II	Active
Control Mechanical Aspirator 30ml	ASP-1029	FDA UDI	Class II	Active
Landmark	LR-N-059	FDA UDI	Class II	Active
XableCath	XC-035-065A	FDA UDI	Class II	Unknown
Control RX-LP Mechanical Thrombectomy System	ASP-1001	FDA UDI	Class II	Active
XableCath	XC-035-090B	FDA UDI	Class II	Unknown
Control 9F Mechanical Thrombectomy System, 60cm	A9-060	FDA UDI	Class II	Active
XableCath	XC-018-145B	FDA UDI	Class II	Unknown
MorTan	MT2000	FDA UDI	Class I	Active
XO Score	S6.50-065	FDA UDI	Class II	Active
Syntervention	4011	FDA UDI	Class I	Active
Knight Microcatheter	2P0-130-B	FDA UDI	Class II	Active
Control RX-LP Mechanical Thrombectomy System, 136cm	ARX-LP6	FDA UDI	Class II	Active
XableCath	XC-035-065B	FDA UDI	Class II	Unknown
Control 10T Mechanical Thrombectomy System Tubing	MT10-100	FDA UDI	Class II	Active

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