# ARCERA GMBH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For ARCERA GMBH · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is Intraarticular hyaluronic acid; EUFLEXXA; product code is 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 06/12/2023; address is Levelingstr. 8 , Munich, Bavaria GERMANY, verified against its source on 2026-09-16.

- **Firm:** ARCERA GMBH _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** GERMANY _(verified: appears in the quote below)_
- **Address:** Levelingstr. 8 , Munich, Bavaria GERMANY _(verified: appears in the quote below)_
- **Date published:** 06/12/2023 _(verified: appears in the quote below)_
- **Product code:** 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: appears in the quote below)_
- **Product:** Intraarticular hyaluronic acid; EUFLEXXA _(verified: appears in the quote below)_

## What the source says

> ARCERA GMBH Date Published : 06/12/2023 Levelingstr. 8 , Munich, Bavaria GERMANY 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 06/12/2023 Desc: Intraarticular hyaluronic acid; EUFLEXXA Notes:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).