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Blom-Singer Replacement Gel Caps, 16 Fr.

by Freudenberg Medical LLC EUDAMEDGUDID

Active European Union

Ref BE 3190

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08482530GELCAPSJ6 Basic UDI-DIDate3 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00813307011491 UDI-DIDate24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Blom-Singer Replacement Gel Caps, 16 Fr. EUDAMED
InHealth Technologies; Blom-Singer GUDID
Generic Name
Tracheoesophageal device insertion capsule
Device Name
Gelcaps
Model / Reference
BE 3190
Primary DI / UDI-DI
00813307011491
Basic UDI-DI
08482530GELCAPSJ6
FDA Product Code
EWL
EMDN Code
A070599 Caps or obturators - other
GMDN Term
Tracheoesophageal device insertion capsule
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.3730
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

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

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

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No