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Disposable vinyl gloves

by Tangshan Hongyun Healthcare Products Co., Ltd.

Ref M(medium size)Model HY02(M-5.0)

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 Number69594355HY02M5UH Basic UDI-DIDate26 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06959435500026 UDI-DIDate18 Jun 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
hongyun
Generic Name
Vinyl examination/treatment glove, non-powdered
Device Name
Disposable vinyl gloves
Model / Reference
HY02(M-5.0) EUDAMED
M(medium size) EUDAMED
HY02 GUDID
Primary DI / UDI-DI
06959435500026
Basic UDI-DI
69594355HY02M5UH
510(k) Number
FDA Product Code
LYZ
EMDN Code
T01020201 Vinyl examination / treatment gloves
GMDN Term
Vinyl examination/treatment glove, non-powdered
Device Class
Class I
Regulation Number
880.6250
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
HY02(M-5.0)
M(medium size)
GUDID
HY02

Manufacturer details

EUDAMED SRN
CN-MF-000001357
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Tangshan Hongyun Healthcare Products Co., Ltd.

See all devices from Tangshan Hongyun Healthcare Products Co., Ltd. →

Properties

  • Single Use
  • Over-the-Counter
  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No