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Sebia

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000003520

Sebia is a medical device manufacturer based in France, with 271 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class A and IVD General; FDA Class I and II) and 1 FDA recall as of 13 Nov 2026.

Devices
271
Registrations
EUDAMEDFDA
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • EUDAMED 165
  • FDA GUDID 108
  • FDA 510(k) 26

A device listed in two registries counts in both.

Device classes
  • EU Class A 117
  • FDA Class I 57
  • FDA Class II 54
  • EU IVD General 36
  • EU Class C 5
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN FR-MF-000003520
  • DUNS 276801933
  • Other registry ID 6387

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

Catalogue271

Newest first, rows 1-50 of 271

Search and filter all 271 devices
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Rows 1-50 of 271

Showing 1-50 of 271

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000003520
Other identifier
6387(not a standard FEI format)
DUNS number
276801933
EU VAT number
FR21672041902
EUDAMED status
Active
EUDAMED registered name
sebia
Registered address
Parc Technologique Léonard de Vinci, CP 8010 Lisses - 91008 EVRY Cedex, Lisses, France
Website
www.sebia.com
Phone
+33 1 69 89 83 31
PRRC contact
Arnaud COLLIN(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2006

    • 29 Aug 2006 Z-0073-2007 Unclassified (pre-2012) Terminated The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction. Distribution: Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico Submission number: K991362

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Sebia, Inc. US

Frequently asked questions

How many devices does SEBIA have in the registry?

The registry currently lists 271 devices for SEBIA. Devices recorded under merged duplicate company entries are counted once.

Which registries list SEBIA's devices?

Among its 50 most recently registered devices, SEBIA has devices listed in EUDAMED (36 devices) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do SEBIA's devices fall under?

Among its 50 most recently registered devices, the classes recorded for SEBIA's devices are Class II and IVD general. Each device page shows its own class and authorisation.

Are there FDA recall records for SEBIA?

FDA recall records list 1 recall initiated by SEBIA, the most recent initiated on 29 Aug 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from SEBIA in the registry?

The most recently registered devices listed for SEBIA include FREE ANTI-LAMBDA 1 mL (SM), FREE ANTI-KAPPA 1 mL (DM), HYDRAGEL 1 BENCE JONES (SM) and ANTI-Ig M 1 mL (DM).

Which FDA establishments are linked to SEBIA?

1 FDA establishment is linked to SEBIA in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.