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AirLife™ Edith 500 HME, Disposable

by AirLife Finland Oy 2 variants

Ref 557056200

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

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10889483586600 Basic UDI-DI 10889483586600UDI-DIDate22 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889483586600 UDI-DI Date28 Mar 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
AirLife™ Edith 500 HME, Disposable EUDAMED
AirLife™ GUDID
Generic Name
Heat/moisture exchanger, single-use
Device Name
AirLife™ Humidification and Filtration
Model / Ref / Catalog
557056200
Primary DI / UDI-DI
10889483586600
Basic UDI-DI
B-10889483586600
FDA Product Code
BYD
EMDN Code
R040102 Antibacterial and antiviral respiratory filters humidifiers
GMDN Term
Heat/moisture exchanger, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5375
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
FI-MF-000001482

Other devices from AirLife Finland Oy

See all devices from AirLife Finland Oy →

Properties

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

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No