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Ganze Swabs

by Xuchang Zhende Surgical Dressing Co., Ltd

Ref P162C126001

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 linked in EUDAMED

A group certificate may exist

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 Number697240330SGP000001SR Basic UDI-DI 06979109839986UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06979109839986 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Ganze Swabs EUDAMED
Gauze Swabs GUDID
Generic Name
Woven gauze roll/sheet
Device Name
gauze 13 threads in DOUBLE packaging sterile by ETO
Model / Reference
P162C126001
Primary DI / UDI-DI
06979109839986
Basic UDI-DI
697240330SGP000001SR
FDA Product Code
NAB
EMDN Code
M0201010101 Cotton gauze, cut, without x-ray detectable thread, sterile
GMDN Term
Woven gauze roll/sheet
Device Class
Class I
Regulation Number
878.4014
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000009222
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Xuchang Zhende Surgical Dressing Co., Ltd.

See all devices from Xuchang Zhende Surgical Dressing Co., Ltd. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Serial Number: No