Skip to content

Gesichtsmaske, DIN EN 14683

by Hans Hepp GmbH & Co. KG

Ref 89114

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
United StatesGUDID listing GUDID Number04007418891141 UDI-DI Date28 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4007418GesichtsmaskenNZ Basic UDI-DI 04007418891141UDI-DIDate16 Jun 2022RegisteredStatusActive

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  • Withdrawn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
Gesichtsmaske, DIN EN 14683 EUDAMED
Medical Face Mask GUDID
Generic Name
Public face mask, single-use
Device Name
Medizinische Gesichtsmasken
Model / Reference
89114
Primary DI / UDI-DI
04007418891141
Basic UDI-DI
4007418GesichtsmaskenNZ
FDA Product Code
QKR
EMDN Code
T020603 Medical use face masks, type i (not for healthcare professionals)
GMDN Term
Public face mask, single-use
Device Class
Class I EUDAMED
N GUDID
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
N

Manufacturer details

EUDAMED SRN
DE-MF-000006024

Other devices from Hans Hepp GmbH & Co. KG

See all devices from Hans Hepp GmbH & Co. KG →

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