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LELO Hex

by Suzhou Armocon Technology Co., Ltd. China EUDAMEDGUDID

Ref 3Model 54mm Product code HISEMDN U110101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07350075022470 Basic UDI-DIDate25 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07350075022470 UDI-DIDate23 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
LELO Hex EUDAMED
HEX Condoms Original 3 Pack (US_TNR) GUDID
Generic Name
Basic male condom, Hevea-latex
Device Name
LELO Hex Natural Rubber Latex Male Condom
Model / Reference
54mm EUDAMED
3 EUDAMED
2472 GUDID
Primary DI / UDI-DI
07350075022470
Basic UDI-DI
B-07350075022470
FDA Product Code
HIS
EMDN Code
U110101 Condoms
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
884.5300
Market of Registration
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
54mm
3
GUDID
2472
Device ClassEUDAMED
Class IIb
GUDID
Class II
Contains LatexEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000025071
Authorised representative
LELOi AB SE-AR-000008546

Other devices from Suzhou Armocon Technology Co., Ltd.

See all devices from Suzhou Armocon Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex YesEUDAMEDNoGUDID
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED a1239b5b-77e6-4c9e-b39d-0e292f048e9e 61 fields · synced 22 Oct 2026
  • FDA UDI 5a95ae98-5a63-4569-ab44-e51c9e6767f6 33 fields · synced 30 May 2026