Unicoglobal, Inc.
South KoreaFDA applicant, unverified
Unicoglobal, Inc. is a medical device manufacturer, with 39 devices listed in FDA GUDID and FDA 510(k) (FDA Class II, Class I and Unclassified) as of 14 Nov 2026.
- Devices
- 39
Registry facts
- Registries
- FDA GUDID 37
- FDA 510(k) 2
- Device classes
- FDA Class II 26
- FDA Class I 11
- FDA Unclassified 2
What Unicoglobal, Inc. makes
Unicoglobal, Inc. manufactures single-use personal protective equipment (PPE) for surgical and medical settings, including reinforced surgical gowns, antimicrobial respirators, isolation gowns, face masks (with and without face shields), surgical aprons, caps, and drape kits. Products are designed for fluid resistance, barrier protection, and compliance with infection control standards.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with some products listed under the National (N) classification. Devices are authorised via FDA 510(k) clearances and the FDA’s Unique Device Identification (UDI) system, ensuring traceability and regulatory compliance.
Catalogue
Search and filter all 39 devicesFrequently asked questions
How many devices does Unicoglobal, Inc. have in the registry?
The registry currently lists 39 devices for Unicoglobal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unicoglobal, Inc.'s devices?
Among its 39 most recently registered devices, Unicoglobal, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Unicoglobal, Inc.'s devices fall under?
Among its 39 most recently registered devices, the classes recorded for Unicoglobal, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unicoglobal, Inc. in the registry?
The most recently registered devices listed for Unicoglobal, Inc. include Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) SG-S2002NS-S, Unico High Performance Surgical Mask SM-301E, ISOLSTION GOWN(COVERALL) IG-C2001 and SURGICAL MASK WITH FACE SHIELD SA-2001MFS.