Ulcer Solutions
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000036842
Ulcer Solutions is a medical device manufacturer based in the United States, with 3 devices listed in EUDAMED (EU Class I) as of 12 Nov 2026.
- Devices
- 3
- Registrations
- EUDAMED
Registry facts
- Registries
- EUDAMED 3
- Device classes
- EU Class I 3
- Top EMDN categories
- Sites and related companies
- Code of Practice AB authorised representative
- Identifiers
- EUDAMED SRN US-MF-000036842
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Code of Practice ABSE
What Ulcer Solutions makes
Ulcer Solutions manufactures off-loading devices designed to reduce pressure on vulnerable areas of the body, including the Heel Keeper Ultra and Heel Keeper AFO. These products are intended for use in treating and preventing pressure injuries, particularly in patients at risk of heel ulcers or related complications.
The company’s portfolio consists of Class I medical devices, which are generally considered low-risk. These devices are listed in the EU’s eudamed registry, ensuring traceability and compliance with European Union medical device regulations. The manufacturer is based in the United States.
Catalogue
Heel Keeper Ultra Ref HG01ULTRA
Regimes: CE MDR Registry: EUDAMEDHeel Keeper Ultra Ref HG01ULTRAXL
Regimes: CE MDR Registry: EUDAMEDHeel Keeper AFO Ref HKAF2
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000036842
- EUDAMED status
- Active
- EUDAMED registered name
- Ulcer Solutions
- EUDAMED abbreviated name
- Ulcer Solutions
- Registered address
- 3101 NE, 169th Way,, WA 98642, Ridgefield,, United States
- Website
- www.ulcersolutions.com/
- facebook.com/UlcerSolutions
- Phone
- +1 541-953-7398
- PRRC contact
- Thomas Wuest
From the company website
Comfortable, cost-effective, and compliance-enhancing off-loading devices for treating and preventing pressure injuries.
Frequently asked questions
How many devices does Ulcer Solutions have in the registry?
The registry currently lists 3 devices for Ulcer Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ulcer Solutions's devices?
Among its 3 most recently registered devices, Ulcer Solutions has devices listed in EUDAMED (3 devices).
What risk classes do Ulcer Solutions's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ulcer Solutions's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ulcer Solutions in the registry?
The most recently registered devices listed for Ulcer Solutions include Heel Keeper Ultra and Heel Keeper AFO.