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Surgical Gowns

by YADU Medical (Henan) Co., Ltd.

Ref SY0130, SYZC0126, SYZC0124, SY0131, SYZC0123510(k) K252301

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252301↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252301 Date4 Feb 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number697539204YDTD01TL Basic UDI-DI Date3 Sep 2025RegisteredStatusActive

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 found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference
SY0130, SYZC0126, SYZC0124, SY0131, SYZC0123
Primary DI / UDI-DI
06975392044526, 06979247710703, 06975392044489, 06975392044519, 06975392044496, 06979247719744
Basic UDI-DI
697539204YDTD01TL, 697539204YDTD59UK, 697539204YDTD58UH
510(k) Number
FDA Product Code
FYA
EMDN Code
T020401, T020402
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4040
EU market of registration
Germany
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000027471
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from YADU Medical (Henan) Co., Ltd.

See all devices from YADU Medical (Henan) Co., Ltd. →

Properties

  • Sterile YesEUDAMEDNoEUDAMED

Other properties (12)

  • 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