Data / Medical devices / Italy / Artiglass SRL
Artiglass SRL: FDA-registered device maker in Due Carrare Padova, Italy, 2 510(k) clearances
Artiglass SRL is registered with the FDA (registration 9680615) in Due Carrare Padova, Italy. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680615
- FEI number
- 3011744364
- Address
- Via Piemonte 13, Due Carrare Padova, Italy, 35020
- Owner or operator
- ARTIGLASS SRL (9010160)
- Roles
- Manufacturer
- First device listed
- April 11, 1994
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | QEH | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 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 |
|---|---|---|---|---|---|---|
| May 19, 2022 | K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | QEH | Substantially Equivalent | Artiglass Srl | accessdata.fda.gov |
| May 3, 2013 | K122416 | ARTIGLASS L. O.R. GLASS SYRINGE | FMF | Substantially Equivalent | Artiglass Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Unit, Syringe, Air And/Or Water
- All makers of Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
Updated May 19, 2022. 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.