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Tracheostoma Valve Housing, Standard

by Freudenberg Medical LLC

Ref BE6038

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08482530TRCHVALVHOUSBH Basic UDI-DI 00813307012559UDI-DIDate31 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813307012559 UDI-DI Date1 Jan 2018ListedStatusListed 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  • Withdrawn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
Tracheostoma Valve Housing, Standard EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic Name
Tracheostomy base plate, reusable
Device Name
Trchvalvhous
Model / Reference
BE6038 EUDAMED
BE 6038 GUDID
Primary DI / UDI-DI
00813307012559
Basic UDI-DI
08482530TRCHVALVHOUSBH
FDA Product Code
BYD
EMDN Code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN Term
Tracheostomy base plate, reusable
Device Class
Class I
Regulation Number
868.5375
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BE6038
GUDID
BE 6038

Manufacturer details

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

Related devices

Category: Gas-sampling/monitoring respiratory tubing, single-use

Other devices from Freudenberg Medical LLC

See all devices from Freudenberg Medical LLC →

Properties

  • Over-the-Counter
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No