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Relastics NLEL38H

by Reliance Orthodontic Products, Inc.

Part of a family of 40 devices: see the family page

Ref NLEL38HModel Relastics

Relastics NLEL38H is a device classified as Class IIa in the EU and Class I in the US made by Reliance Orthodontic Products, Inc., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 840479ELASTICSGX) and listed in FDA GUDID since 17 Sep 2025 (UDI-DI 00840479202938), active as of 25 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number840479ELASTICSGX Basic UDI-DI 00840479202938UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840479202938 UDI-DI Date17 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 840479ELASTICSGX registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 00840479202938 listed 17 Sep 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840479202938
  2. Registered EUDAMED 840479ELASTICSGX

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  • Withdrawn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
Non-Latex Elastics EUDAMED
Relastics GUDID
Generic name
Orthodontic inter-arch elastic band
Model / reference
NLEL38H, Relastics
Primary DI / UDI-DI
00840479202938
Basic UDI-DI
840479ELASTICSGX
FDA product code
ECI
EMDN code
Q010404 Orthodontic elastics, chains and springs
GMDN term
Orthodontic inter-arch elastic band
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthodontic inter-arch elastic band

Similar devices in this category

Other devices filed under ORTHODONTIC ELASTICS, CHAINS AND SPRINGS.

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)