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Entegrion, Inc.

Active in EUDAMED

United Statesfrom EUDAMED address EUDAMED SRN US-MF-000034059

Devices
1
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Entegrion, Inc. makes

Entegrion, Inc. manufactures hemostatic agents, including the STASILON FR, a topical product designed to control bleeding by promoting rapid blood clotting at surgical sites.

The company’s portfolio is regulated under the FDA’s Class II (U) device classification, with individual products authorised via the 510(k) clearance pathway. The manufacturer is based in the United States.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Stasilon Fr Ref K072890

    Active Regimes: 510(k) Registry: 510(k) Class:—

Company details

EUDAMED SRN
US-MF-000034059
EUDAMED status
Active
EUDAMED registered name
Entegrion, Inc.
EUDAMED abbreviated name
Entegrion
Phone
+1 (919) 536-1500
PRRC contact
Richard Martin(public in EUDAMED)

Frequently asked questions

How many devices does Entegrion, Inc. have in the registry?

The registry currently lists 1 device for Entegrion, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Entegrion, Inc.'s devices?

Among its 1 most recently registered device, Entegrion, Inc. has devices listed in FDA 510(k) (1 device).

What are the newest devices from Entegrion, Inc. in the registry?

The most recently registered devices listed for Entegrion, Inc. include STASILON FR.

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