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Gammex Non-Latex

by Ansell Healthcare Europe NV 7 variants

Ref 8513 6.5

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414566GNL340851NV Basic UDI-DI 00884792385121UDI-DIDate6 Mar 2023RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00884792385121 UDI-DI Date7 Feb 2022ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Gammex Non-Latex EUDAMED
Gammex GUDID
Generic Name
Polychloroprene surgical glove, non-powdered
Device Name
Polychloroprene Surgical Gloves
Model / Ref / Catalog
8513 6.5 EUDAMED
8513 GUDID
Primary DI / UDI-DI
00884792385121
Basic UDI-DI
5414566GNL340851NV
FDA Product Code
KGO
EMDN Code
T01010201 Polychloropren surgical gloves
GMDN Term
Polychloroprene surgical glove, non-powdered
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
8513 6.5
GUDID
8513
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
BE-MF-000000691

Other devices from Ansell Healthcare Europe NV

See all devices from Ansell Healthcare Europe NV →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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