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InHealth Technologies - InHealth Technologies

by Freudenberg Medical LLC

Ref FM-1004

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00848253000954 Basic UDI-DI 00848253000954UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848253000954 UDI-DI Date1 Jan 2017ListedStatusListed 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  • Withdrawn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
Adjustable Bi-Flanged Fistula Prosthesis - 38mm EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic Name
Hypopharyngeal fistula occluder
Model / Reference
FM-1004 EUDAMED
FM 1004 GUDID
Primary DI / UDI-DI
00848253000954
Basic UDI-DI
B-00848253000954
FDA Product Code
LRC
EMDN Code
P0299 ENT prostheses - other
GMDN Term
Hypopharyngeal fistula occluder
Models / Variants
InHealth Technologies
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.4420
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FM-1004
GUDID
FM 1004
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Hypopharyngeal fistula occluder

Other devices from Freudenberg Medical LLC

See all devices from Freudenberg Medical LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No