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
High Pressure Syringe	300202	EUDAMEDFDA UDI	Class IIa	Active
Pressure Connecting Tube	680302	EUDAMED	Class I	Active
High Pressure Syringe	100302	EUDAMEDFDA UDI	Class IIa	Active
Contrast Media Injectors	ANT200200L	EUDAMED	Class IIb	Active
High Pressure Syringe	300104B	EUDAMEDFDA UDI	Class IIa	Active
High Pressure Syringe	300103A	EUDAMEDFDA UDI	Class IIa	Active
Multi-Patient Syringe System	M410402	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT192121	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT122121	EUDAMED	Class IIb	Active
Pressure Connecting Tube	HBR120	EUDAMEDFDA UDI	Class I	Active
Multi-Patient Syringe System	M110401C	EUDAMED	Class IIa	Active
Multi-Patient Syringe System	M410502	EUDAMED	Class IIa	Active
Pressure Connecting Tube	HBR180	EUDAMEDFDA UDI	Class I	Active
Multi-Patient Syringe System	M110403	EUDAMED	Class IIa	Active
Multi-Patient Syringe System	M300102	EUDAMED	Class IIa	Active
Pressure Connecting Tube	610005	EUDAMED	Class I	Active
Multi-Patient Syringe System	R108110	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT181163	EUDAMED	Class IIb	Active
Pressure Connecting Tube	HBR200	EUDAMEDFDA UDI	Class I	Active
Pressure Connecting Tube	700208	EUDAMED	Class I	Active
Pressure Connecting Tube	600104	EUDAMED	Class I	Active
High Pressure Syringe	100104A	EUDAMED	Class IIa	Active
Disposable Pressure Transducer	PT151163	EUDAMED	Class IIb	Active
Inflation Device	ID1220	EUDAMEDFDA UDI	Class I	Active
High Pressure Syringe	200105B	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT151110	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT141103	EUDAMEDFDA UDI	Class IIb	Active
Pressure Connecting Tube	HBR025	EUDAMED	Class I	Active
High Pressure Syringe	200105A	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT141123	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT163103	EUDAMEDFDA UDI	Class IIb	Active
Disposable Pressure Transducer	PT181103	EUDAMEDFDA UDI	Class IIb	Active
Multi-Patient Syringe System	M310601	EUDAMED	Class IIa	Active
Patient Line	612709	EUDAMED	Class I	Active
Pressure Connecting Tube	801104	EUDAMED	Class I	Active
Hemostasis Valve	HV232E00	EUDAMED	Class I	Active
Pressure Connecting Tube	600102	EUDAMED	Class I	Active
High Pressure Syringe	100201	EUDAMEDFDA UDI	Class IIa	Active
Disposable Pressure Transducer	PT182163	EUDAMED	Class IIb	Active
Multi-Patient Syringe System	M310621	EUDAMED	Class IIa	Active
High Pressure Syringe	400102	EUDAMED	Class IIa	Active
Pressure Connecting Tube	614150	EUDAMEDFDA UDI	Class I	Active
High Pressure Syringe	200205	EUDAMEDFDA UDI	Class IIa	Active
Contrast Media Injectors	ANT065115	EUDAMED	Class IIb	Active
Disposable Pressure Transducer	PT112121	EUDAMEDFDA UDI	Class IIb	Active
Pressure Connecting Tube	600105	EUDAMED	Class I	Active
Contrast Media Injectors	ANT000200	EUDAMED	Class IIb	Active
Multi-Patient Syringe System	M100302	EUDAMED	Class IIa	Active
Patient Line	612801	EUDAMED	Class I	Active
Disposable Pressure Transducer	PT143103	EUDAMEDFDA UDI	Class IIb	Active

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