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Accutouch

by Medline International France SAS 4 variants

Ref MDS192075

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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0080196DC40ANS2Y Basic UDI-DI 00080196167978UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00080196167978 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution

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 22 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  • Withdrawn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
Accutouch EUDAMED
Medline GUDID
Generic Name
Vinyl examination/treatment glove, non-powdered
Device Name
Examination Gloves Accutouch
Model / Ref / Catalog
MDS192075
Primary DI / UDI-DI
00080196167978
Basic UDI-DI
0080196DC40ANS2Y
Unit of Use DI
10080196167975
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
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000000676

Other devices from Medline International France

See all devices from Medline International France →

Properties

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

Other properties (20)

  • 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
  • Expiration Date: No