Teknimed SAS
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000001224 FEI 3003854593
Teknimed SAS is a medical device manufacturer based in France, with 4 devices listed in EUDAMED and FDA 510(k) (EU Class I; FDA Class II) as of 14 Nov 2026.
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 2
- FDA 510(k) 2
- Device classes
- EU Class I 2
- FDA Class II 2
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000001224
- FDA FEI 3003854593
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment
What Teknimed SAS makes
TEKNIMED SAS manufactures surgical implant templates (reusable), polyester non-bioabsorbable multifilament sutures, and intraosseous infusion kits. Their product examples include spinal cement systems (such as NuVasive Maximum Viscosity and HV 1300), surgical instruments like screwdrivers, femoral aimers, drills of various sizes (Ø6mm, Ø7mm, Ø10mm, Ø11mm), vertebroplasty and biopsy needles, and syringes (PureKit Syringes 1.5cc/MV and standard 1.5cc syringes).
The company's devices span Class I, II, IIa, IIb, and III classifications and are listed in both the EUDAMED database and the FDA 510(k) registry. TEKNIMED SAS is based in France (FR).
Catalogue
Cohesion Bone Cement Ref K103816
Regimes: 510(k) Registry: 510(k)Gentafix® (1, 3, 3MV) Ref K242216
Regimes: 510(k) Registry: 510(k)Tap Ø5.5mm Ref T067503
Regimes: CE MDR Registry: EUDAMEDA’LINK’S® Instrumentation Case Ref T067294
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000001224
- FDA FEI number
- 3003854593
- 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
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 11 Aug 2029
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 establishments
- Teknimed FR
Frequently asked questions
How many devices does TEKNIMED SAS have in the registry?
The registry currently lists 4 devices for TEKNIMED SAS. Devices recorded under merged duplicate company entries are counted once.
Which registries list TEKNIMED SAS's devices?
Among its 4 most recently registered devices, TEKNIMED SAS has devices listed in EUDAMED (2 devices) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TEKNIMED SAS's devices fall under?
Among its 4 most recently registered devices, the classes recorded for TEKNIMED SAS's devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for TEKNIMED SAS?
EUDAMED lists 2 certificates for TEKNIMED SAS (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 SAS in the registry?
The most recently registered devices listed for TEKNIMED SAS include COHESION BONE CEMENT, GENTAFIX® (1, 3, 3MV), Tap Ø5.5mm and A’LINK’S® Instrumentation Case.
Which FDA establishments are linked to TEKNIMED SAS?
1 FDA establishment is linked to TEKNIMED SAS in the registry; they are listed on the company page.