Q: What types of medical devices does Apex (Guangzhou) Tools & Orthopedics Co. primarily manufacture?

Apex (Guangzhou) Tools & Orthopedics Co. specializes in disposable surgical irrigation and aspiration systems, which are used during procedures to flush wounds or cavities while removing fluids. They also produce reusable surgical irrigation system nozzles, closed-wound or centesis drainage receptacles (for collecting fluids from wounds or body cavities), and canisters designed for negative-pressure wound therapy systems, which help manage wounds by applying controlled suction.

Question 1

What types of medical devices does Apex (Guangzhou) Tools & Orthopedics Co. primarily manufacture?

Accepted Answer

Apex (Guangzhou) Tools & Orthopedics Co. manufactures disposable surgical irrigation and aspiration systems, including reusable surgical irrigation nozzles. Their portfolio also includes closed-wound and centesis drainage receptacles, as well as canisters for negative-pressure wound therapy systems. Examples include the itool® ApexPulse™, AWI systems, MICROAIRE® devices, and MicroPort® products.

The company’s devices are classified under EU regulations as Class I or Class II/IIa and are listed in the EUDAMED database. They are also registered in the FDA’s Unique Device Identifier (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.

Question 2

Where is Apex (Guangzhou) Tools & Orthopedics Co. based, and how does this affect its devices?

Accepted Answer

The company is based in China. While the country of origin does not inherently determine a device’s safety or compliance, it influences regulatory pathways. For example, devices listed in the EUDAMED database and the FDA’s UDI system must meet specific regulatory standards regardless of manufacturer location, ensuring they comply with global medical device regulations.

Question 3

Which regulatory registries list devices manufactured by Apex (Guangzhou) Tools & Orthopedics Co., and why?

Accepted Answer

Devices from Apex (Guangzhou) Tools & Orthopedics Co. are listed in EUDAMED (the European Union’s medical device database) and the FDA’s UDI system (Unique Device Identifier). These registries track devices that have undergone the necessary authorization processes in the EU and the US, respectively, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are devices from Apex (Guangzhou) Tools & Orthopedics Co. classified under EU regulations?

Accepted Answer

Under EU regulations, Apex’s devices fall into Class I (generally low-risk, like some surgical instruments) or Class II/IIa (moderate-risk, such as irrigation/aspiration systems or wound therapy components). Classification determines the regulatory scrutiny and authorization requirements—Class II/IIa devices undergo stricter evaluation due to their role in critical procedures or patient safety.

Question 5

Why might a healthcare provider look for Apex’s devices in registries like EUDAMED or FDA UDI?

Accepted Answer

Healthcare providers consult these registries to verify a device’s authorized status, ensuring it meets safety and performance standards before use. For example, EUDAMED confirms compliance with EU Medical Device Regulations (MDR), while the FDA UDI system provides traceability and recall information. Listing in these databases signals that the device has undergone the required regulatory processes, reducing risks for patients and clinicians.

Device	Model / Reference	Registries	Class	Status
itool® ApexPulse™	201-00-50	FDA UDI	Class II	Active
Awi	210-07	FDA UDI	Class I	Active
Awi	209-03	FDA UDI	Class II	Active
itool® ApexPulse™	201-04-00	FDA UDI	Class II	Active
Awi	209-00	FDA UDI	Class II	Active
Microaire®	201-00-37	FDA UDI	Class II	Active
itool® ApexPulse™	201-03-00	FDA UDI	Class II	Active
Awi	209-04	FDA UDI	Class II	Active
MicroPort®	201-00-52	FDA UDI	Class II	Active
Awi	209-06	FDA UDI	Class II	Active
Awi	209-00	FDA UDI	Class II	Active
Microaire®	201-03-00	FDA UDI	Class II	Active
Awi	210-08	FDA UDI	Class I	Active
Microaire®	201-00-51	FDA UDI	Class II	Active
Awi	209-00-47	FDA UDI	Class II	Active
Microaire®	201-00-52	FDA UDI	Class II	Active
itool® ApexPulse™	201-00-52	FDA UDI	Class II	Active
Microaire®	201-00-44	FDA UDI	Class II	Active
itool® ApexPulse™	201-00-46	FDA UDI	Class II	Active
Awi	209-04	FDA UDI	Class II	Active
Awi	209-00-68	FDA UDI	Class II	Active
Itool	209-01	FDA UDI	Class II	Active
Awi	209-06	FDA UDI	Class II	Active
Awi	209-00-68	FDA UDI	Class II	Active
Awi	209-06	FDA UDI	Class II	Active
itool® ApexPulse™	201-00-80	FDA UDI	Class II	Active
itool® ApexPulse™	201-00-51	FDA UDI	Class II	Active
Awi	209-05	FDA UDI	Class II	Active
Awi	210-05	FDA UDI	Class I	Active
itool® ApexPulse™	201-02-00	FDA UDI	Class II	Active
Awi	210-07	FDA UDI	Class I	Active
Microaire®	201-04-00	FDA UDI	Class II	Active
Itool	209-02	FDA UDI	Class II	Active
Itool	209-01	FDA UDI	Class II	Active
Awi	210-05	FDA UDI	Class I	Active
itool® ApexPulse™	201-00-44	FDA UDI	Class II	Active
Microaire®	201-00-80	FDA UDI	Class II	Active
Itool	209-02	FDA UDI	Class II	Active
MicroPort®	2010400	FDA UDI	Class II	Active
Awi	209-04	FDA UDI	Class II	Active
Awi	210-08	FDA UDI	Class I	Active
itool® ApexPulse™	201-05-00	FDA UDI	Class II	Active
Awi	210-07	FDA UDI	Class I	Active
Awi	209-00-68	FDA UDI	Class II	Active
Microaire®	201-00-46	FDA UDI	Class II	Active
Awi	210-00-64	FDA UDI	Class II	Active
Awi	210-07	FDA UDI	Class I	Active
Microaire®	201-00-50	FDA UDI	Class II	Active
Awi	210-05	FDA UDI	Class I	Active
Awi	209-00-68	FDA UDI	Class II	Active

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