Data / Medical devices / France / Laboratoires Urgo
Laboratoires Urgo: FDA-registered device maker in CHEVIGNY SAINT SAUVEUR Cote-d'Or, France, 4 510(k) clearances
Laboratoires Urgo is registered with the FDA (registration 9615662) in CHEVIGNY SAINT SAUVEUR Cote-d'Or, France. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615662
- FEI number
- 3007671324
- Address
- Excellence 2000 2 Avenue De Strasbourg, CHEVIGNY SAINT SAUVEUR Cote-d'Or, France, 21800
- Owner or operator
- LABORATOIRES URGO (9029420)
- Roles
- Manufacturer
- First device listed
- February 19, 1997
- Registered through
- 2026
- Brand names listed
- URGO K1, URGO K2; URGO K2 Lite, URGOCLEAN Pad, URGOCLEAN Rope, UrgoClean, Urgocell Ag/Silver, Urgoclean Ag, Urgotul and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | 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 |
|---|---|---|---|---|---|---|
| August 7, 2015 | K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver | FRO | Substantially Equivalent | Laboratoires Urgo | accessdata.fda.gov |
| March 18, 2013 | K123219 | URGOCLEAN ABSORBENT WOUND DRESSING | FRO | Substantially Equivalent | Laboratoires Urgo | accessdata.fda.gov |
| January 29, 2007 | K062559 | URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER | FRO | Substantially Equivalent | Laboratoires Urgo | accessdata.fda.gov |
| July 27, 2006 | K061220 | URGOTUL AG | FRO | Substantially Equivalent | Laboratoires Urgo | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Drug
- All makers of Bandage, Elastic
- All makers of Dressing, Wound, Occlusive
Updated August 7, 2015. 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.