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Wearever

by Prime Life Fibers Inc. 87 variants

Ref M100GRY4XModel M100

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 Number081865902M1007L Basic UDI-DI 00818659021051UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818659021051 UDI-DI Date23 Sep 2025ListedStatusListed 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  • Withdrawn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

Generic Name
Incontinence pants, reusable
Model / Reference
M100 EUDAMED
M100GRY4X EUDAMED
M100GRAY4X GUDID
Primary DI / UDI-DI
00818659021051
Basic UDI-DI
081865902M1007L
Direct Marketing DI
00818659021051
FDA Product Code
EYQ
EMDN Code
T04010102 Shaped incontinence nappies
GMDN Term
Incontinence pants, reusable
Device Class
Class I
Regulation Number
876.5920
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M100
M100GRY4X
GUDID
M100GRAY4X

Manufacturer details

EUDAMED SRN
US-MF-000014613
Authorised representative
QNET B.V. NL-AR-000002695

Other devices from Prime Life Fibers Inc.

See all devices from Prime Life Fibers Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No