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Synexmed(Shenzhen)Company Limited

ChinaFDA applicant, unverified

Devices
2

What Synexmed(Shenzhen)Company Limited makes

Synexmed(Shenzhen) Company Limited manufactures the IM BAND, a device for intramuscular injection monitoring, and the E-PASS, a portable electronic pass system for controlled substance tracking or access control in healthcare settings.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Im Band Ref K113600

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • E-Pass Ref K113148

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Synexmed(Shenzhen)Company Limited have in the registry?

The registry currently lists 2 devices for Synexmed(Shenzhen)Company Limited. Devices recorded under merged duplicate company entries are counted once.

Which registries list Synexmed(Shenzhen)Company Limited's devices?

Among its 2 most recently registered devices, Synexmed(Shenzhen)Company Limited has devices listed in FDA 510(k) (2 devices).

What risk classes do Synexmed(Shenzhen)Company Limited's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Synexmed(Shenzhen)Company Limited's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Synexmed(Shenzhen)Company Limited in the registry?

The most recently registered devices listed for Synexmed(Shenzhen)Company Limited include IM BAND and E-PASS.

Generated automatically from registry data and not verified by a human reviewer.