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R82 A/S

Active in EUDAMED

Denmarkfrom SRN EUDAMED FDA SRN DK-MF-000000772 FEI 3001657382

R82 A/S is a medical device manufacturer based in Denmark, with 341 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class I) and 4 FDA recalls as of 14 Nov 2026.

Devices
341
Registrations
EUDAMEDFDA
FDA recalls
40 ongoing since 2021 (1 open in total)
1 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 257
  • EUDAMED 142
  • FDA 510(k) 4

A device listed in two registries counts in both.

Device classes
  • FDA Class I 198
  • EU Class I 142
  • FDA Class II 1
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN DK-MF-000000772
  • FDA FEI 3001657382
  • DUNS 308022169

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

Catalogue341

Newest first, rows 1-50 of 341

Search and filter all 341 devices
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Rows 1-50 of 341

Showing 1-50 of 341

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
DK-MF-000000772
FDA FEI number
3001657382
DUNS number
308022169
EU VAT number
1001054116
EUDAMED status
Active
EUDAMED registered name
R82 A/S
Registered address
3, Parallelvej, 8751, Gedved, Denmark
Website
etac.com
PRRC contact
Dianna Jensen(public in EUDAMED)

FDA recalls4

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

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 1
  • 2020 1
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 8 Dec 2021 Z-0569-2022 Class II Terminated The chrome surface of the push brace can crack during use, potentially cutting the user. Distribution: Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of North Carolina and California and the countries of Czech Republic, Finland, Germany, Greece, Holland, Italy, Japan, Norway, Poland, Russia, Sweden, and United Kingdom.

  • 2020

    • 6 Mar 2020 Z-1858-2020 Class II Terminated The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. Distribution: NC

  • 2019

    • 28 Mar 2019 Z-1315-2019 Class II Terminated Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat. Distribution: US in the states of NC

  • 2017

    • 30 Jun 2017 Z-0441-2019 Class II Open since 2017 Replacement campaign on all units that have a gas spring head in aluminum. Distribution: Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland,…
      Full distribution text Nationwide Denmark, Germany, Spain, Finland, France, Great Britain, Island, Netherlands, Norway, Poland, Switzerland, Japan, Australia and New Zealand

Frequently asked questions

How many devices does R82 A/S have in the registry?

The registry currently lists 341 devices for R82 A/S. Devices recorded under merged duplicate company entries are counted once.

Which registries list R82 A/S's devices?

Among its 50 most recently registered devices, R82 A/S has devices listed in EUDAMED (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do R82 A/S's devices fall under?

Among its 50 most recently registered devices, the classes recorded for R82 A/S's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for R82 A/S?

FDA recall records list 4 recalls initiated by R82 A/S, the most recent initiated on 8 Dec 2021. 1 of them is recorded as ongoing. 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 R82 A/S in the registry?

The most recently registered devices listed for R82 A/S include Multi Frame, R82 Scallop 3, R82 x:panda SIZE-2 and R82 x:panda SIZE-1.

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