Reference Source

ARCERA GMBH · 89-08 · GERMANY

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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:

accessdata.fda.gov, retrieved 2026-09-15

Source

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