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SurgiSeal Stylus topical skin adhesive

by HB Fuller, Medical Adhesive Technologies

Ref SS-050S, SS-035T

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161011↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00891375002030 Basic UDI-DI Date6 May 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK161011 Date8 Nov 2016IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device Name
SurgiSeal Stylus topical skin adhesive
SurgiSeal topical skin adhesive
Model / Reference
SS-050S, SS-035T
Primary DI / UDI-DI
00891375002030, 00891375002009
Basic UDI-DI
B-00891375002030, B-00891375002009
EMDN Code
H90010102 Synthetic glues
Device Class
Class IIa
EU market of registration
Spain
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000037862
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from HB Fuller, Medical Adhesive Technologies

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No