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Auditdata A/S

Active in EUDAMED

Denmarkfrom SRN EUDAMED FDA SRN DK-MF-000011415 FEI 3008386587

Auditdata A/S is a medical device manufacturer based in Denmark, with 55 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and IIb) as of 13 Nov 2026.

Devices
55
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 50
  • EUDAMED 18
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • FDA Class II 43
  • EU Class IIa 11
  • EU Class IIb 1
Identifiers
  • EUDAMED SRN DK-MF-000011415
  • FDA FEI 3008386587
  • DUNS 310385849

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

Catalogue55

Newest first, rows 1-50 of 55

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
DK-MF-000011415
FDA FEI number
3008386587
DUNS number
310385849
EU VAT number
1012239528
EUDAMED status
Active
EUDAMED registered name
Auditdata A/S
EUDAMED abbreviated name
Auditdata A/S
Registered address
10B, Wildersgade, 1408, Copenhagen, Denmark
PRRC contact
Denys Lebedev(public in EUDAMED)

Frequently asked questions

How many devices does Auditdata A/S have in the registry?

The registry currently lists 55 devices for Auditdata A/S. Devices recorded under merged duplicate company entries are counted once.

Which registries list Auditdata A/S's devices?

Among its 50 most recently registered devices, Auditdata A/S has devices listed in EUDAMED (13 devices), FDA 510(k) (1 device) and FDA GUDID (46 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Auditdata A/S's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Auditdata A/S's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Auditdata A/S in the registry?

The most recently registered devices listed for Auditdata A/S include 3000 Real Ear BC1 - 6.35, 3000 Real Ear BC1 - 2000-1, 3000 Real Ear BC1 - DIN-8 and 3000 Real Ear IN1 Insert Earphone.

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