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Sign in to claim this brandShenZhen Antmed Co., Ltd
China·CN-MF-000029659
Last updated May 27, 2026
What ShenZhen Antmed Co., Ltd makes
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.
Frequently asked questions
What types of medical devices does ShenZhen Antmed Co., Ltd primarily manufacture?
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.
Where is ShenZhen Antmed Co., Ltd based, and how does this affect its regulatory compliance?
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.
Which regulatory registries list devices manufactured by ShenZhen Antmed Co., Ltd?
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.
How are devices from ShenZhen Antmed Co., Ltd classified under EU regulations?
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.
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 18, Jinhui Ave., Pingshan New District, Shenzhen, China
- Website
- www.antmed.com/
- —
- —
- [email protected]
- Phone
- +86 755 86060992
- PRRC Contact
- Xia Gu
- EUDAMED SRN
- CN-MF-000029659
- FDA FEI Number
- —
- DUNS Number
- 527221254
Catalogue (362)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Antmed | PT182203 | FDA UDI | Class II | Active |
| Antmed | 618150 | FDA UDI | Class II | Active |
| Antmed | 614180 | FDA UDI | Class II | Active |
| Antmed | 710075 | FDA UDI | Class II | Active |
| Antmed | PT171108 | FDA UDI | Class II | Active |
| Antmed | 200113 | FDA UDI | Class II | Active |
| Antmed | PT143108 | FDA UDI | Class II | Active |
| Antmed | PT171208 | FDA UDI | Class II | Active |
| Antmed | PT122208 | FDA UDI | Class II | Active |
| Antmed | 606120 | FDA UDI | Class II | Active |
| Antmed | PT123108 | FDA UDI | Class II | Active |
| Antmed | PT131108 | FDA UDI | Class II | Active |
| Antmed | PT111108 | FDA UDI | Class II | Active |
| Antmed | CS0001 | FDA UDI | Class II | Active |
| Antmed | PT133208 | FDA UDI | Class II | Active |
| Antmed | PT142208 | FDA UDI | Class II | Active |
| Antmed | 619150 | FDA UDI | Class II | Active |
| Antmed | 200202 | FDA UDI | Class II | Active |
| Antmed | 700150 | FDA UDI | Class II | Active |
| Antmed | PT162108 | FDA UDI | Class II | Active |
| Antmed | 603075 | FDA UDI | Class II | Active |
| Antmed | PT153108 | FDA UDI | Class II | Active |
| Antmed | PT141203 | FDA UDI | Class II | Active |
| Antmed | PT173108 | FDA UDI | Class II | Active |
| Antmed | PT142108 | FDA UDI | Class II | Active |
| Antmed | PT182108 | FDA UDI | Class II | Active |
| Antmed | PT161108 | FDA UDI | Class II | Active |
| Antmed | 607150 | FDA UDI | Class II | Active |
| Antmed | 200111 | FDA UDI | Class II | Active |
| Antmed | HBF150 | FDA UDI | Class II | Active |
| Antmed | 200301A | FDA UDI | Class II | Active |
| Antmed | PT163203 | FDA UDI | Class II | Active |
| Antmed | HBF100 | FDA UDI | Class II | Active |
| Antmed | CS0101 | FDA UDI | Class II | Active |
| Antmed | PT121108 | FDA UDI | Class II | Active |
| Antmed | 700075 | FDA UDI | Class II | Active |
| Antmed | 611018 | FDA UDI | Class II | Active |
| Antmed | PT153203 | FDA UDI | Class II | Active |
| Antmed | 500111 | FDA UDI | Class II | Active |
| Antmed | PT163208 | FDA UDI | Class II | Active |
| Antmed | CS0401 | FDA UDI | Class II | Active |
| Antmed | PT172108 | FDA UDI | Class II | Active |
| Antmed | 612180 | FDA UDI | Class II | Active |
| Antmed | TR2012 | FDA UDI | Class II | Active |
| Antmed | HBF120 | FDA UDI | Class II | Active |
| Antmed | PT161208 | FDA UDI | Class II | Active |
| Antmed | HBF075 | FDA UDI | Class II | Active |
| Antmed | PT172208 | FDA UDI | Class II | Active |
| Antmed | CS0010 | FDA UDI | Class II | Active |
| Antmed | CS0220 | FDA UDI | Class II | Active |
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