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MICROFLEX SafeGrip SG-375

by Ansell Healthcare Europe NV 4 variants

Ref SG-375-M Size M

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414566MF63893EC Basic UDI-DI 00769799037535UDI-DIDate11 Jun 2025RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00769799037535 UDI-DI Date17 Mar 2022ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
MICROFLEX SafeGrip SG-375 EUDAMED
Microflex GUDID
Generic Name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Device Name
Latex Examination/Treatment Gloves
Model / Ref / Catalog
SG-375-M Size M EUDAMED
SG-375-M GUDID
Primary DI / UDI-DI
00769799037535
Basic UDI-DI
5414566MF63893EC
FDA Product Code
LYY, LZC
EMDN Code
T010201 Latex examination / treatment gloves
GMDN Term
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Device Class
Class I
Regulation Number
880.6250
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SG-375-M Size M
GUDID
SG-375-M

Manufacturer details

EUDAMED SRN
BE-MF-000000691

Other devices from Ansell Healthcare Europe NV

See all devices from Ansell Healthcare Europe NV →

Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: 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
  • Expiration Date: No