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Fluid Resistant Procedure mask

by LHM Medical Technology (Hong Kong) Limited 6 variants

Ref LHM-E1301

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, self-declared

Class I: no certifier involved

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 Number48971121300174V Basic UDI-DI 04897112130017UDI-DIDate8 Mar 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04897112130017 UDI-DI Date12 Apr 2021ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Lhm
Generic Name
Surgical/medical face mask, single-use
Model / Reference
LHM-E1301
Primary DI / UDI-DI
04897112130017
Basic UDI-DI
48971121300174V
Unit of Use DI
94897112130010
FDA Product Code
FXX
EMDN Code
T020604 Medical use face masks, type II and iir
GMDN Term
Surgical/medical face mask, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4040
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
HK-MF-000007144
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Lhm Medical Technology (Hong Kong) Limited

See all devices from Lhm Medical Technology (Hong Kong) Limited →

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number

Other properties (21)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No