Data / Medical devices / United States / DGI Group LLC
DGI Group LLC: FDA-registered device maker in Lakewood, NJ, United States, 2 510(k) clearances
DGI Group LLC is registered with the FDA (registration 3014527929) in Lakewood, NJ, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 18, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014527929
- Address
- 910 E County Line Rd, Lakewood, NJ, United States, 08701
- Owner or operator
- DGI GROUP LLC (10057329)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 6, 2023
- Registered through
- 2026
- Brand names listed
- Claritag Advanced, Claritag RX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2023 | K222356 | Claritag Advanced | GEH | Substantially Equivalent | Dgi Technologies | accessdata.fda.gov |
| October 31, 2019 | K190747 | Claritag | GEH | Substantially Equivalent | Dgi Technologies | accessdata.fda.gov |
Compare with other makers
Updated May 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.