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Einmalhandschuhe, L, DIN EN 455-1, 2, 3

by Hans Hepp GmbH & Co. KG 2 variants

Ref 92402

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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 Number04007418924023 UDI-DI Date11 Aug 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4007418Einmalhandschuhe97 Basic UDI-DI 04007418924023UDI-DIDate13 Jun 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Einmalhandschuhe, L, DIN EN 455-1, 2, 3 EUDAMED
Disposable Gloves Size L GUDID
Generic Name
Vinyl examination/treatment glove, non-powdered
Device Name
Einmalhandschuhe
Model / Reference
92402
Primary DI / UDI-DI
04007418924023
Basic UDI-DI
4007418Einmalhandschuhe97
510(k) Number
FDA Product Code
LYZ
EMDN Code
T01020201 Vinyl examination / treatment gloves
GMDN Term
Vinyl examination/treatment glove, non-powdered
Device Class
Class I
Regulation Number
880.6250
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000006024

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Properties

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