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ScarSil 85000

by Scar Heal

Ref 85010Model 88888

ScarSil 85000 is a Class I device made by Scar Heal, registered in EUDAMED on 17 Feb 2026 (Basic UDI-DI 64279088888W2) and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 00642790850108), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number64279088888W2 Basic UDI-DI 00642790850108UDI-DIDate17 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00642790850108 UDI-DI Date31 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 64279088888W2 registered 17 Feb 2026 Active
  • FDA GUDID UDI-DI 00642790850108 listed 31 Jul 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00642790850108
  2. Registered EUDAMED 64279088888W2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ScarSil
Generic name
Scar-management dressing, single-use
Device name
RejuvaSil Silicone Scar Gel
Model / Ref / Catalog
88888 EUDAMED
85010 EUDAMED
85000 GUDID
Primary DI / UDI-DI
00642790850108 EUDAMED
00642790850009 GUDID
Basic UDI-DI
64279088888W2
FDA product code
MDA
EMDN code
M04040701 Silicone dressings, non-combined
GMDN term
Scar-management dressing, single-use
Device class
Class I
Regulation number
878.4025
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
88888
85010
GUDID
85000
Primary DI / UDI-DIEUDAMED
00642790850108
GUDID
00642790850009

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00642790850108; FDA GUDID lists 00642790850009), so their flags are not compared.

Related devices

Category: Scar-management dressing, single-use

Similar devices in this category

Other devices filed under SILICONE DRESSINGS, NON-COMBINED.

Other devices from Scar Heal

See all devices from Scar Heal →

Properties

  • Single use
  • Premarket exempt
Other properties (23, all answered No)