Graham Medical Technologies, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000008507
- Devices
- 14
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Emergo Europe B.V.NL
What Graham Medical Technologies, LLC makes
Graham Medical Technologies produces surgical instruments and implants for foot stabilization, including sizing tools, drivers, and the HyProCure Sinus Tarsi Implant System. The portfolio also includes the OsteoWedge Opening Wedge Bone Locking System, designed for bone correction procedures. These products are intended for procedures such as sinus tarsi stabilization and subtalar joint interventions.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIb, with corresponding entries in the EUDAMED and FDA 510(k) registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesCompany details
- EUDAMED SRN
- US-MF-000008507
- EU VAT number
- 20-0105595
- EUDAMED status
- Active
- EUDAMED registered name
- Graham Medical Technologies, LLC
- EUDAMED abbreviated name
- GraMedica
- Registered address
- 236, Mill Street, 48307, Rochester, United States
- Website
- www.gramedica.com
- [email protected]
- Phone
- +001 586-677-9600
- PRRC contact
- Angela Recchia
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 8 Jul 2030
Notified body 1639 1 certificate
- US25/00000280 Supplemented
Quality management system EU MDR
- Issued
- 10 Jun 2026
- Expires
- 8 Jul 2030
- Reason
- Other
From the company website
Titanium sinus tarsi stabilization that fixes the upstream cause of foot pain — motion-preserving, under 20 minutes, weight-bearing in days.
Frequently asked questions
How many devices does Graham Medical Technologies, LLC have in the registry?
The registry currently lists 14 devices for Graham Medical Technologies, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Graham Medical Technologies, LLC's devices?
Among its 14 most recently registered devices, Graham Medical Technologies, LLC has devices listed in EUDAMED (10 devices) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Graham Medical Technologies, LLC's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Graham Medical Technologies, LLC's devices are Class I, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Graham Medical Technologies, LLC?
EUDAMED lists 1 certificate for Graham Medical Technologies, LLC (quality management system) under MDR. The most recent was issued on 2026-06-10.
What are the newest devices from Graham Medical Technologies, LLC in the registry?
The most recently registered devices listed for Graham Medical Technologies, LLC include HyProCure Sinus Tarsi Instrument Set, HyProCure Sizer 06, HyProCure Sizer 10 and HyProCure Sizer 05.