Amplitude
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000003453 FEI 3009590742
- Devices
- 1,253
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Amplitude makes
Amplitude manufactures tibial inserts, including meniscal designs for partial knee replacements, and modular metallic hip and knee prostheses. Their portfolio includes coated and uncoated femoral stems, acetabular shells, and femoral head prostheses in metallic and ceramic materials. Polyethylene acetabular liners and modular hip components are also part of their offerings.
All listed devices fall under FDA Class II regulation and are recorded in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, where these products are tracked for compliance and traceability.
Catalogue
Search and filter all 1,253 devicesShowing 1-50 of 1,253
Company details
- EUDAMED SRN
- FR-MF-000003453
- FDA FEI number
- 3009590742
- EU VAT number
- FR 83 414 448 464
- EUDAMED status
- Active
- EUDAMED registered name
- AMPLITUDE
- EUDAMED abbreviated name
- ORTHO IMPLANTS
- Registered address
- 11, Cours Jacques Offenbach, 26000, VALENCE, France
- Website
- www.amplitude-ortho.com
- PRRC contact
- Mireille LEMERY
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 3 Jun 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 822547 Active
Technical documentation EU MDR
- Issued
- 16 Jun 2026
- Expires
- 3 Jun 2030
- Reason
- Change approved
Frequently asked questions
How many devices does Amplitude have in the registry?
The registry currently lists 1253 devices for Amplitude. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amplitude's devices?
Among its 50 most recently registered devices, Amplitude has devices listed in EUDAMED (50 devices).
What risk classes do Amplitude's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Amplitude's devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Amplitude?
EUDAMED lists 1 certificate for Amplitude (technical documentation) under MDR. The most recent was issued on 16 Jun 2026.
What are the newest devices from Amplitude in the registry?
The most recently registered devices listed for Amplitude include ANATOMIC Fixed Bearing Insert Size 2 Thickness 20 mm, ANATOMIC Fixed Bearing Insert Size 7 Thickness 20 mm, UNI SCORE All-poly Tibial Component Cemented Size 4 Thickness 10 mm and ANATOMIC Fixed Bearing Insert Size 1 Thickness 14 mm.