Data / Medical devices / Austria / Croma-Pharma GMBH
Croma-Pharma GMBH: FDA-registered device maker in Leobendorf Niederosterreich, Austria, 2 PMA approvals
Croma-Pharma GMBH is registered with the FDA (registration 3002806738) in Leobendorf Niederosterreich, Austria. It lists 1 device type. The FDA files 2 PMA approvals under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806738
- Address
- Industriezeile 6, Leobendorf Niederosterreich, Austria, 2100
- Owner or operator
- CROMA-PHARMA GmbH (10094137)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 17, 2025
- Registered through
- 2027
- Brand names listed
- saypha MagIQ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Dermal, For Aesthetic Use | LMH | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | P250021 | saypha® ChiQ | LMH | 2 | October 8, 2026 | accessdata.fda.gov |
| September 8, 2025 | P240008 | saypha® MagIQ | LMH | 0 | September 8, 2025 | accessdata.fda.gov |
Compare with other makers
Updated October 8, 2026. 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.