ARCERA GMBH · 89-08 · GERMANY
For ARCERA GMBH, import alert is 89-08; country is GERMANY; 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)"; 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 2026-09-30.
- Firm
- ARCERA GMBH verified
- 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
- Address
- Levelingstr. 8 , Munich, Bavaria GERMANY verified
- Date published
- 06/12/2023 verified
- Product code
- 87 M - - OZ Acid, hyaluronic, intraarticular verified
- Product
- Intraarticular hyaluronic acid; EUFLEXXA verified
What the source says
ARCERA GMBH Date Published : 06/12/2023 Levelingstr. 8 , Munich, Bavaria GERMANY
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 06/12/2023 Desc: Intraarticular hyaluronic acid; EUFLEXXA Notes:
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.