FDA Device Establishments · JSON-LD · Markdown
FEI 3002806269 · Manufacture Medical Device · Status: Active
| FEI Number | 3002806269 |
|---|---|
| Owner / Operator | ATOS MEDICAL AB (#8032044) |
| Address | KRAFTGATAN 8, HORBY Skane, SE-24235, SE |
| Mandatory US Agent | COLOPLAST CORP. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EWL |
| Regulation § (21 CFR) | 874.3730 |
| Proprietary names | Provox FreeHands FlexiVoice Medium; Provox FreeHands FlexiVoice Set Plus; Provox FreeHands FlexiVoice Set; Provox FreeHands HME Moist; Provox FreeHands HME Flow; Provox FreeHands FlexiVoice Strong; Provox FreeHands FlexiVoice Arch; Provox FreeHands FlexiVoice Light; Provox FreeHands FlexiVoice XtraStrong; Provox Life FreeHands FlexiVoice Set Plus |
Source: openFDA. Public-domain (CC0).