Skip to content

SpeakFree HME EasyFlow, 6 pack

by Freudenberg Medical LLC United States EUDAMEDGUDID

Ref BE 1090EF-6

Product code BYDEMDN R040201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00848253002286 UDI-DIDate6 Oct 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08482530SPEAKFREEGJ Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
SpeakFree HME EasyFlow, 6 pack EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic Name
Heat/moisture exchanger, single-use
Device Name
Speakfree
Model / Reference
BE 1090EF-6
Primary DI / UDI-DI
00848253002286
Basic UDI-DI
08482530SPEAKFREEGJ
FDA Product Code
BYD
EMDN Code
R040201 Tracheostomy humidifiers
GMDN Term
Heat/moisture exchanger, single-use
Device Class
Class I
Regulation Number
868.5375
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000023823
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Freudenberg Medical LLC

See all devices from Freudenberg Medical LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (21)
  • 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
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 869b9238-101d-4e9a-9123-b57ad2f5a632 61 fields · synced 22 Oct 2026
  • FDA UDI dfdec66a-2607-4ca1-92da-2548e37f1844 33 fields · synced 23 Oct 2026