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Steam Eye Mask

by Henan Chaoya Medical Equipment Co.Ltd. China EUDAMEDGUDID

Ref 185mm*80mm 28piecesModel 175mmx70mm、170mmx75mm、185mmx75mm、185mmx80mm、185mmx85mm、160mmx 60mm、180mmx80mm、195mmx80mm Product code HMPEMDN R03010180

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06950396345510 UDI-DIDate26 Feb 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number69503963353068W Basic UDI-DIDate4 Feb 2026RegisteredStatusActive

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/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Steam Eye Mask EUDAMED
Medi Grade GUDID
Generic Name
Eye hot/cold therapy mask, single-use
Model / Reference
175mmx70mm、170mmx75mm、185mmx75mm、185mmx80mm、185mmx85mm、160mmx 60mm、180mmx80mm、195mmx80mm EUDAMED
185mm*80mm 28pieces EUDAMED
185mm*80mm GUDID
Primary DI / UDI-DI
06950396345510
Basic UDI-DI
69503963353068W
FDA Product Code
HMP
EMDN Code
R03010180 Artificial ventilation masks - accessories
GMDN Term
Eye hot/cold therapy mask, single-use
Device Class
Class I
Regulation Number
878.4440
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000041471
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Henan Chaoya Medical Equipment Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No

Sources (2)

  • EUDAMED 5e5782f0-eb0f-4f53-9e5b-e2c8b0c15518 61 fields · synced 24 Oct 2026
  • FDA UDI 0a34b0c9-4c23-4fe6-9a6a-a54d39ee5e39 32 fields · synced 22 Oct 2026