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Teknimed

Active in EUDAMED

Registered as TEKNIMED SAS in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000001224

Part of Teknimed SAS

Teknimed is a medical device manufacturer based in France, with 529 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class III, I and IIb; FDA Class II) and 2 FDA recalls as of 14 Nov 2026.

Devices
529
Registrations
EUDAMED
FDA recalls
21 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 451
  • FDA GUDID 181
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class III 299
  • FDA Class II 133
  • EU Class I 76
  • EU Class IIb 8
  • EU Class IIa 7
  • FDA Class I 5
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN FR-MF-000001224
  • DUNS 764746723

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA recalls

What Teknimed makes

Teknimed manufactures synthetic bone matrix implants, bioabsorbable orthopaedic screws, and antimicrobial orthopaedic cements. Their portfolio includes polymer-based cement restrictors, non-bioabsorbable vertebral bone fillers, and kits for cement preparation and delivery. Examples include synthetic TCP screws, antimicrobial cement systems, and bioabsorbable bone filler materials designed for orthopaedic applications.

Teknimed’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearances and the FDA’s Unique Device Identifier (UDI) system. The company operates from the United States.

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

Catalogue529

Newest first, rows 1-50 of 529

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Rows 1-50 of 529

Showing 1-50 of 529

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000001224
SRN (system / procedure pack)
FR-PR-000001226
DUNS number
764746723
EU VAT number
FR26352949960
EUDAMED status
Active
EUDAMED registered name
TEKNIMED SAS
Registered address
8, rue du Corps Franc Pommiès, 65500, Vic-en-Bigorre, France
PRRC contact
Solange VAN DE MOORTELE(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 11 Aug 2029

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • MDR 737954 Active

    Technical documentation EU MDR

    Issued
    12 Aug 2024
    Expires
    11 Aug 2029
  • MDR 737965 Active

    Technical documentation EU MDR

    Issued
    12 Aug 2024
    Expires
    11 Aug 2029

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 TEKNIMED, the earliest on 2006-08-31 and the most recent on 2022-12-15. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2022

    • 15 Dec 2022 Z-1099-2023 Class II Ongoing Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. Distribution: Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain,…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
      Submission number: K161114

  • 2006

    • 31 Aug 2006 Z-0423-2007 Unclassified (pre-2012) Terminated The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box. Distribution: Nationwide Submission number: K031826

Frequently asked questions

How many devices does TEKNIMED have in the registry?

The registry currently lists 529 devices for TEKNIMED. Devices recorded under merged duplicate company entries are counted once.

Which registries list TEKNIMED's devices?

Among its 50 most recently registered devices, TEKNIMED has devices listed in EUDAMED (50 devices).

What risk classes do TEKNIMED's devices fall under?

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

Are there FDA recall records for TEKNIMED?

FDA recall records list 2 recalls initiated by TEKNIMED, the most recent initiated on 15 Dec 2022. 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 EUDAMED certificates are recorded for TEKNIMED?

EUDAMED lists 2 certificates for TEKNIMED (technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 12 Aug 2024.

What are the newest devices from TEKNIMED in the registry?

The most recently registered devices listed for TEKNIMED include CorTTape screw - Ø8mm L30mm, VV+, Eclipse NG - Ø8mm L24mm and ZR+.

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