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
Aspire Max 5 Aspiration Catheter 55cm	A5-055	FDA UDI	Class II	Unknown
XableCath	XC-014-065A	FDA UDI	Class II	Unknown
XableCath	XC-018-065A	FDA UDI	Class II	Unknown
Control 6F Mechanical Thrombectomy System 135cm	A6-135	FDA UDI	Class II	Active
Control 10T Mechanical Thrombectomy Filter	MT10	FDA UDI	Class II	Active
Spinr	5X-GW	FDA UDI	Class II	Active
Control 9F Mechanical Thrombectomy System, 90cm	A9-090	FDA UDI	Class II	Active
Control Mechanical Aspirator	30-ASP	FDA UDI	Class II	Active
SAM Medical	RT200-G1-EN	FDA UDI	Class II	Active
XableCath	XC-018-090B	FDA UDI	Class II	Unknown
Stream Dx	SDX01	FDA UDI	Class II	Active
Control 5F Mechanical Thrombectomy System 135cm	A5-135	FDA UDI	Class II	Active
Spinr	SPN-1005	FDA UDI	Class II	Active
Control 11F Mechanical Thrombectomy System	ASP-1021	FDA UDI	Class II	Active
XableCath	XC-014-145A	FDA UDI	Class II	Unknown
XableCath	XC-018-145A	FDA UDI	Class II	Unknown
CATS Tonometer	CATS-R	FDA UDI	Class II	Active
XableCath	XC-018-065B	FDA UDI	Class II	Unknown
Control 10T Mechanical Thrombectomy System Tubing, Female Suction	ASP-1040	FDA UDI	Class II	Active
XO Cross 14	C14-090-H	FDA UDI	Class II	Active
Control 11F Mechanical Thrombectomy System, 60cm	A11-060	FDA UDI	Class II	Active
Control 10T Mechanical Thrombectomy System Tubing, Female Suction	MT10-100-F	FDA UDI	Class II	Active
Control 10T Mechanical Thrombectomy System Tubing, 3-Pack	MT10-100-3	FDA UDI	Class II	Active
PenBlade Safety Scalpel	#15 Blade	FDA UDI	Class I	Active
Knight Microcatheter	2P0-130-S	FDA UDI	Class II	Active
SAM IO ® Needle - 45mm	IO707W	EUDAMEDFDA UDI	Class IIa	Active
ZIEN IO Intraosseous Access System	K240915	FDA 510(k)	Class II	Active
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing	K162159	FDA 510(k)	Class II	Active
LANDMARK REBOA Catheter	K214060	FDA 510(k)	Class II	Active
SAM IO ® Needle - 25mm	IO706W	EUDAMEDFDA UDI	Class IIa	Active
SAM IO ® Adaptor	IO742	EUDAMEDFDA UDI	Class I	Active
The Morgan mor-FLEX Lens	MT6673	EUDAMEDFDA UDI	Class IIa	Active
SAM IO® Driver	IO700	EUDAMEDFDA UDI	Class I	Active
The Morgan Lens Delivery Set	MT202	EUDAMED	Class I	Active
Medi-Duct	MT63	EUDAMED	Class I	Active
SAM IO ® Stabilizer	IO740	EUDAMEDFDA UDI	Class I	Active
SAM IO ® Needle - 15mm	IO705W	EUDAMEDFDA UDI	Class IIa	Active

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