Engineered Custom Mfg., Inc.
Country not established
- Devices
- 1
What Engineered Custom Mfg., Inc. makes
Engineered Custom Mfg., Inc. manufactures sealed container systems designed for sterilization and containment of medical devices, including variants sized for small, medium, and large loads. These containers are intended for use in healthcare settings to protect sterile items during transport and storage.
The company’s products fall under FDA Class II devices and are listed via 510(k) clearance in the United States. The portfolio is regulated under US FDA standards, with no additional international registries referenced.
Catalogue
Steritite Sealed Container(SC08F, SC06F, SC04F, SC08Q, SC06Q, SC04Q, SC08H, SC06H, SC04H) Ref K960738
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Engineered Custom Mfg., Inc. have in the registry?
The registry currently lists 1 device for Engineered Custom Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Engineered Custom Mfg., Inc.'s devices?
Among its 1 most recently registered device, Engineered Custom Mfg., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Engineered Custom Mfg., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Engineered Custom Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Engineered Custom Mfg., Inc. in the registry?
The most recently registered devices listed for Engineered Custom Mfg., Inc. include STERITITE SEALED CONTAINER(SC08F, SC06F, SC04F, SC08Q, SC06Q, SC04Q, SC08H, SC06H, SC04H).