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Wearever HDL600-BGE-2X-EA

by Prime Life Fibers Inc. EUDAMEDGUDID

Active European Union

Ref HDL600BGE2XModel HDL600

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081006584HDL600SE Basic UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810065846471 UDI-DIDate23 Sep 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Wearever
Generic Name
Incontinence pants, reusable
Model / Reference
HDL600 EUDAMED
HDL600BGE2X EUDAMED
HDL600-BGE-2X-EA GUDID
Primary DI / UDI-DI
00810065846471
Basic UDI-DI
081006584HDL600SE
Direct Marketing DI
00810065846471
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
HDL600
HDL600BGE2X
GUDID
HDL600-BGE-2X-EA

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