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Individual EMA Straps(EMAST21Y) EMA 21 YELLOW

by Ema Sleep Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850077473210 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Individual EMA Straps(EMAST21Y)
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis
Model / Ref / Catalog
EMA 21 YELLOW, EMAST21Y
Primary DI / UDI-DI
00850077473210
FDA Product Code
LRK
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis
Device Class
Class II
Regulation Number
872.5570
GUDID distribution status
In Commercial Distribution

Other devices from Ema Sleep Incorporated

See all devices from Ema Sleep Incorporated →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No