Skip to content

medimaps group SA

Active in EUDAMED

Switzerlandfrom SRN EUDAMED FDA SRN CH-MF-000039146 FEI 3010208539

medimaps group SA is a medical device manufacturer based in Switzerland, with 16 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I and IIa) and 2 FDA recalls as of 14 Nov 2026.

Devices
16
Registrations
EUDAMEDFDA
FDA recalls
21 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 9
  • EUDAMED 4
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 11
  • EU Class I 2
  • EU Class IIa 2
  • FDA Class I 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN CH-MF-000039146
  • FDA FEI 3010208539
  • DUNS 486330728

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
Med-Imaps SASUFR

What medimaps group SA makes

Medimaps Group SA makes various medical devices, including bone absorptiometric x-ray systems, bone densitometry phantoms, CT phantoms, diagnostic ultrasound phantoms, and general-purpose diagnostic x-ray phantoms. They also produce application software for basic diagnostic x-ray systems and multi-modality diagnostic imaging phantoms. Their products include the TBS iNsight and TBS Osteo devices.

The company's portfolio is regulated under Class I, Class II, and Class IIa devices and is listed in registries such as Eudamed, FDA 510(k), and FDA UDI. Medimaps Group SA is based in Switzerland.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

Search and filter all 16 devices
Skip device list

  • CORELab 1.0

    Listed Registry: GUDID Class:I

  • CORELab

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • TBS Reveal Ref REVTBSRV10

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TBS iNsight 4.0

    Active Regimes: 510(k) Registry: GUDID Class:II

  • TBS iNsight 3.1.1

    Listed Registry: GUDID Class:II

  • TBS iNsight 3.1.0

    Withdrawn Registry: GUDID Class:II

  • TBS iNsight 3.0.2.0

    Listed Registry: GUDID Class:II

  • TBS iNsight 3.1.2

    Listed Registry: GUDID Class:II

  • Phantom 3

    Listed Registry: GUDID Class:II

  • TBS iNsight 3.0.3.0

    Listed Registry: GUDID Class:II

  • Medimaps TBS iNsight 3.0.1.0

    Withdrawn Registry: GUDID Class:II

  • TBS iNsight Ref K152299 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • TBS iNsight (V4) Ref K243218

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tbs Insight Ref K121716

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tbs Osteo Ref OS-TBSi

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TBS Osteo Ref OS-PTM

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-16 of 16

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
CH-MF-000039146
FDA FEI number
3010208539
DUNS number
486330728
EUDAMED status
Active
EUDAMED registered name
Medimaps Group SA
EUDAMED abbreviated name
MIG
Registered address
36A, Chemin du Champ-des-Filles, 1228, Plan-les-Ouates, Switzerland
Phone
0225150114
PRRC contact
Alexia Pleinecassagne(public in EUDAMED)

FDA recalls2

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

FDA recall records list 2 recalls initiated by medimaps group SA, the earliest on 2016-10-03 and the most recent on 2025-02-03. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

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

1 initiated before 2017

  • 2025

    • 3 Feb 2025 Z-1250-2025 Class II Ongoing Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. Distribution: Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA. International:…
      Full distribution text Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA. International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY
      Submission number: K152299

  • 2016

    • 3 Oct 2016 Z-0369-2017 Class II Terminated The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded. Distribution: Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries:…
      Full distribution text Worldwide Distribution - US Nationwide - in the states of: IL, NC, CA, DE, NY, MD, WI, MN. And the following countries: France,Thailand, Croatia, Canada, Italy, Spain, Russian Federation, Ukraine, Lithuania, South Africa, Brazil, Lebanon, Saudi Arabia, Korea, China Portugalm Iraq, Syrian Arab Republic, Czech Republic, Australia, Belgium, Austria, Romania, New Zealand, Switzerland, Hong Kong, Sweden, Mexico, Islamic Republic of Iran, Serbia, Netherlands, Denmark, and UK.
      Submission number: K152299

Frequently asked questions

How many devices does medimaps group SA have in the registry?

The registry currently lists 16 devices for medimaps group SA. Devices recorded under merged duplicate company entries are counted once.

Which registries list medimaps group SA's devices?

Among its 16 most recently registered devices, medimaps group SA has devices listed in EUDAMED (4 devices), FDA 510(k) (3 devices) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do medimaps group SA's devices fall under?

Among its 16 most recently registered devices, the classes recorded for medimaps group SA's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for medimaps group SA?

FDA recall records list 2 recalls initiated by medimaps group SA, the most recent initiated on 3 Feb 2025. 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 medimaps group SA in the registry?

The most recently registered devices listed for medimaps group SA include CORELab 1.0, CORELab, TBS Reveal and TBS iNsight 4.0.

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