Data / Medical devices / Spain / Laboratorios Grifols, S.A.
Laboratorios Grifols, S.A.: FDA-registered device maker in PARETS DEL VALLES Barcelona, Spain, 4 510(k) clearances
Laboratorios Grifols, S.A. is registered with the FDA (registration 3002807257) in PARETS DEL VALLES Barcelona, Spain. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 19, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807257
- Address
- Pol. Levante C/Can Guasch, 2, PARETS DEL VALLES Barcelona, Spain, 08150
- Owner or operator
- LABORATORIOS GRIFOLS, S.A. (9056285)
- Roles
- Manufacturer
- First device listed
- April 25, 2005
- Registered through
- 2026
- Brand names listed
- GRI-BAG, GRI-FILL 2 Ways Set, GRI-FILL 6 to 1 Set, Gri-Fill Peristaltic Set, Gri-fill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, I.V. | KPE | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | 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 |
|---|---|---|---|---|---|---|
| October 19, 2017 | K162216 | GRI-FILL PERISTALTIC SET | LHI | Substantially Equivalent | Laboratorios Grifols, S.A. | accessdata.fda.gov |
| January 27, 2010 | K093182 | SET GRI-FILL 3.0 | LHI | Substantially Equivalent | Laboratorios Grifols, S.A. | accessdata.fda.gov |
| February 25, 2005 | K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | LHI | Substantially Equivalent | Laboratorios Grifols, S.A. | accessdata.fda.gov |
| December 30, 2003 | K033916 | GRI-BAG, GRI-BAG AP | KPE | Substantially Equivalent | Laboratorios Grifols, S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 29, 2005 | 34243 | Not yet classified | Terminated | Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compoun | When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, I.V.
- All makers of System/Device, Pharmacy Compounding
- All makers of Filter, Infusion Line
- All makers of Set, I.V. Fluid Transfer
Updated October 19, 2017. 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.