Skip to content

NewGel+ Silicone Gel Sheeting NG-301S1

by Newmedical Technology, Inc.

Ref NG-301S1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081646502NGSG3 Basic UDI-DI 00816465020848UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816465020848 UDI-DI Date7 Aug 2025ListedStatusListed GUDID: in commercial distribution

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 22 Oct 2026.

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  • Withdrawn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
NewGel+ EUDAMED
NewGel+ Silicone Gel Sheeting GUDID
Generic Name
Scar-management dressing, reusable
Model / Reference
NG-301S1
Primary DI / UDI-DI
00816465020848
Basic UDI-DI
081646502NGSG3
510(k) Number
FDA Product Code
MDA
EMDN Code
M04040701 Silicone dressings, non-combined
GMDN Term
Scar-management dressing, reusable
Device Class
Class I
Regulation Number
878.4025
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K041704)

Show all (12)

Other devices from Newmedical Technology, Inc.

See all devices from Newmedical Technology, Inc. →

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No