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Breathe Easy Internal Nasal Splint 20-10500

by Invotec International, Inc.

Ref 20-10500Model Internal Nasal Splint

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081850102IntNasalSplintHX Basic UDI-DI 00818501020751UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818501020751 UDI-DI Date6 Dec 2022ListedStatusListed 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.

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  • Withdrawn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
Breath-Easy EUDAMED
Breathe Easy Internal Nasal Splint GUDID
Generic Name
Intranasal splint, non-biodegradable
Model / Ref / Catalog
20-10500, Internal Nasal Splint
Primary DI / UDI-DI
00818501020751
Basic UDI-DI
081850102IntNasalSplintHX
FDA Product Code
LYA
EMDN Code
Q0399 ENT devices - other
GMDN Term
Intranasal splint, non-biodegradable
Device Class
Class I
Regulation Number
874.4780
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Other devices from Invotec International, Inc.

See all devices from Invotec International, Inc. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Serial Number: No
  • Manufacturing Date: No