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Foam Stoma Protector, Tan, 2.4''Lx2.0''W (6cm x 5cm) 30 pk

by Freudenberg Medical LLC

Ref BE 6215

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, self-declared

Class I: no certifier involved

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 Number08482530FOAMSTOMAPROT43 Basic UDI-DI 00813307012795UDI-DIDate21 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813307012795 UDI-DI Date1 Jan 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Foam Stoma Protector, Tan, 2.4''Lx2.0''W (6cm x 5cm) 30 pk EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic Name
Tracheostoma protector, reusable
Device Name
Foamstomaprot
Model / Reference
BE 6215
Primary DI / UDI-DI
00813307012795
Basic UDI-DI
08482530FOAMSTOMAPROT43
FDA Product Code
KGX
EMDN Code
R9099 Respiratory and anaesthesia devices - other
GMDN Term
Tracheostoma protector, reusable
Device Class
Class I
Regulation Number
880.5240
EU market of registration
Netherlands
GUDID distribution status
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

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Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

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