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Wearever LHD200WHT5XL

by Prime Life Fibers Inc.

Ref HDL200WHT5XLModel HDL200

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081387701HDL200YZ Basic UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813877013215 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  • Withdrawn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

Trade Name
Wearever
Generic Name
Incontinence pants, reusable
Model / Reference
HDL200 EUDAMED
HDL200WHT5XL EUDAMED
LHD200WHT5XL GUDID
Primary DI / UDI-DI
00813877013215
Basic UDI-DI
081387701HDL200YZ
Direct Marketing DI
00813877013215
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
HDL200
HDL200WHT5XL
GUDID
LHD200WHT5XL

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