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Scar Heal

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000038554

Scar Heal is a medical device manufacturer based in the United States, with 21 devices listed in FDA GUDID and EUDAMED (EU Class I; FDA Class I) as of 14 Nov 2026.

Devices
21
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 20
  • EUDAMED 19

A device listed in two registries counts in both.

Device classes
  • EU Class I 17
  • FDA Class I 4
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000038554
  • DUNS 014302733

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
MDSS GmbHDE

What Scar Heal makes

Scar Heal manufactures silicone-based scar-management dressings and gels designed for single-use and reusable applications. Their portfolio includes silicone sheets in various sizes, tailored for different body areas such as the breast, and silicone gels for topical scar treatment. Products like ScarSil, Scar Fx, and RejuvaSil are formulated to support scar healing and reduction through consistent moisture retention and pressure application.

The company’s devices are classified as Class I under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Scar Heal operates from the United States, adhering to applicable domestic and international medical device regulations.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

Newest first, rows 1-21 of 21

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Rows 1-21 of 21

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000038554
DUNS number
014302733
EUDAMED status
Active
EUDAMED registered name
Scar Heal
EUDAMED abbreviated name
SH
Registered address
9843, 18th St North, 33716, St Petersburg, United States
Phone
727-535-0022
PRRC contact
Lori Brandon(public in EUDAMED)

Frequently asked questions

How many devices does Scar Heal have in the registry?

The registry currently lists 21 devices for Scar Heal. Devices recorded under merged duplicate company entries are counted once.

Which registries list Scar Heal's devices?

Among its 21 most recently registered devices, Scar Heal has devices listed in EUDAMED (19 devices) and FDA GUDID (20 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Scar Heal's devices fall under?

Among its 21 most recently registered devices, the classes recorded for Scar Heal's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Scar Heal in the registry?

The most recently registered devices listed for Scar Heal include ScarSil 85015, Scar Esthetique 60000, Scar Fx 10648 and ScarSil 85000.

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