Q: What kinds of invasive medical devices does ShenZhen Antmed Co., Ltd produce, and why are they considered invasive?

ShenZhen Antmed Co., Ltd manufactures invasive devices like invasive blood pressure transducer sets, in-line arterial blood sampling sets, and angiographic syringes, which are designed to penetrate the skin or enter the body’s vascular system. These devices are classified as invasive because they involve direct contact with the circulatory system or internal tissues, requiring higher safety standards to minimize risks like infection or injury during use.

Question 1

What types of medical devices does ShenZhen Antmed Co., Ltd primarily manufacture?

Accepted Answer

ShenZhen Antmed Co., Ltd specializes in invasive medical devices, including systems for monitoring and sampling blood pressure, such as invasive blood pressure transducer sets and in-line arterial blood sampling sets. They also produce radiographic procedure tubing, contrast medium injection systems (including syringes), angiographic syringes, angiography kits, and reusable bone surgical tools like bone awls. Additionally, their portfolio includes human-derived bone matrix implants, which are used in orthopedic procedures.

Question 2

Where is ShenZhen Antmed Co., Ltd based, and how does this affect its regulatory compliance?

Accepted Answer

ShenZhen Antmed Co., Ltd is based in China. While the country of origin does not inherently determine regulatory compliance, it means the company must adhere to international standards like those of the EU and the FDA when placing devices on markets such as the European Union or the United States. Their devices are registered in the EUDAMED database (for EU compliance) and the FDA’s UDI system, indicating they meet the necessary regulatory requirements for those regions.

Question 3

Which regulatory registries list devices manufactured by ShenZhen Antmed Co., Ltd?

Accepted Answer

Devices from ShenZhen Antmed Co., Ltd are listed in two major regulatory registries: EUDAMED, the European database for medical devices, and the FDA’s UDI (Unique Device Identification) system, which tracks devices marketed in the United States. These registries ensure transparency and traceability of their products in their respective markets.

Question 4

How are devices from ShenZhen Antmed Co., Ltd classified under EU regulations?

Accepted Answer

Under EU medical device regulations, ShenZhen Antmed Co., Ltd’s devices fall into different risk-based classes: Class I (lowest risk, e.g., some reusable surgical tools), Class IIa (moderate risk, e.g., certain blood pressure monitoring systems), Class IIb (higher risk, such as contrast medium injection systems), and Class II (intermediate risk, like some angiography kits). The classification determines the level of scrutiny, testing, and regulatory oversight required before these devices can be placed on the market.

Question 5

What kinds of invasive medical devices does ShenZhen Antmed Co., Ltd produce, and why are they considered invasive?

Accepted Answer

ShenZhen Antmed Co., Ltd manufactures invasive medical devices including blood pressure transducer sets, radiographic tubing, and arterial blood sampling systems. Their portfolio also covers contrast medium injection syringes, angiographic syringes, angiography kits, and reusable bone awls. Human-derived bone matrix implants are another product line.

The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb. Their products are registered in the EUDAMED database and the FDA’s UDI system. The manufacturer is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Device	Model / Reference	Registries	Class	Status
Disposable Pressure Transducer	PT112103	EUDAMEDFDA UDI	Class IIb	Active
Disposable Pressure Transducer	PT152103	EUDAMEDFDA UDI	Class IIb	Active
Pressure Connecting Tube	HBR075	EUDAMEDFDA UDI	Class I	Active
Disposable Pressure Transducer	PT132103	EUDAMEDFDA UDI	Class IIb	Active
Disposable Pressure Transducer	PT141108	EUDAMEDFDA UDI	Class IIb	Active
Disposable Pressure Transducer	PT131103	EUDAMEDFDA UDI	Class IIb	Active
Multi-Patient Syringe System	M400104	EUDAMED	Class IIa	Active
Multi-Patient Syringe System	M100102	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT173121	EUDAMED	Class IIb	Active
Multi-Patient Syringe System	R400101	EUDAMED	Class IIa	Active
Multi-Patient Syringe System	R300105	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT182103	EUDAMEDFDA UDI	Class IIb	Active
High Pressure Syringe	300102	EUDAMEDFDA UDI	Class IIa	Active
Hemostasis Valve	HV220D00	EUDAMED	Class I	Active
High Pressure Syringe	180302	EUDAMED	Class IIa	Active
High Pressure Syringe	300104A	EUDAMEDFDA UDI	Class IIa	Active
High Pressure Syringe	200103	EUDAMEDFDA UDI	Class IIa	Active
High Pressure Syringe	500101	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT171103	EUDAMEDFDA UDI	Class IIb	Active
High Pressure Syringe	300106	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT131121	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT111105	EUDAMED	Class IIb	Active
High Pressure Syringe	400104	EUDAMEDFDA UDI	Class IIa	Active
High Pressure Syringe	300302	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT141105	EUDAMED	Class IIb	Active
Multi-Patient Syringe System	M110102	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT152105	EUDAMED	Class IIb	Active
High Pressure Syringe	100202	EUDAMEDFDA UDI	Class IIa	Active
Multi-Patient Syringe System	R100102	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT141121	EUDAMED	Class IIb	Active
Multi-Patient Syringe System	M110101	EUDAMED	Class IIa	Active
Multi-Patient Syringe System	R400307	EUDAMED	Class IIa	Active
Injection Tubing System	804102	EUDAMED	Class IIa	Active
High Pressure Syringe	200107A	EUDAMED	Class IIa	Active
Pressure Connecting Tube	680312	EUDAMED	Class I	Active
Disposable Pressure Transducer	PT183163	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT181121	EUDAMED	Class IIb	Active
High Pressure Syringe	300103B	EUDAMEDFDA UDI	Class IIa	Active
Multi-Patient Syringe System	R300311	EUDAMED	Class IIa	Active
High Pressure Syringe	100103	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT172103	EUDAMEDFDA UDI	Class IIb	Active
Disposable Pressure Transducer	PT162163	EUDAMED	Class IIb	Active
High Pressure Syringe	200301	EUDAMEDFDA UDI	Class IIa	Active
High Pressure Syringe	200101	EUDAMEDFDA UDI	Class IIa	Active
Multi-Patient Syringe System	R300106	EUDAMED	Class IIa	Active
Pressure Connecting Tube	700206	EUDAMED	Class I	Active
High Pressure Syringe	300105	EUDAMEDFDA UDI	Class IIa	Active
Pressure Connecting Tube	801101	EUDAMED	Class I	Active
High Pressure Syringe	200107	EUDAMEDFDA UDI	Class IIa	Active
Multi-Patient Syringe System	M110201	EUDAMED	Class IIa	Active

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