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Wearever

by Prime Life Fibers Inc. 87 variants

Ref HDL100BGE5XLModel HDL100

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081387701HDL100YU Basic UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813877013796 UDI-DIDate23 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  • Withdrawn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
HDL100 EUDAMED
HDL100BGE5XL EUDAMED
LHD100BGE5XL GUDID
Primary DI / UDI-DI
00813877013796
Basic UDI-DI
081387701HDL100YU
Direct Marketing DI
00813877013796
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
HDL100
HDL100BGE5XL
GUDID
LHD100BGE5XL

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