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Gibeck IPN044104

by Teleflex Incorporated

Ref 28062

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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-04026704348121 Basic UDI-DI 04026704348121UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704348121 UDI-DI Date16 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Iso Gard Hepa Small S EUDAMED
Gibeck GUDID
Generic Name
Microbial medical gas filter, single-use
Device Name
Iso-Gard Hepa,small Straight
Model / Ref / Catalog
28062, IPN044104
Primary DI / UDI-DI
04026704348121
Basic UDI-DI
B-04026704348121
510(k) Number
FDA Product Code
CAH
EMDN Code
R040101 Antibacterial and antiviral respiratory filters
GMDN Term
Microbial medical gas filter, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5260
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
28062
GUDID
IPN044104
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Microbial medical gas filter, single-use

Cleared under the same submission (K954828)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No