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Disposable sampling swab

by Jiangsu HanHeng Medical Technology Co., Ltd. 188 variants

Ref A-011Model A-series

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 Number697369781001QQ Basic UDI-DI 06973697810112UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06973697810112 UDI-DI Date10 Nov 2022ListedStatusListed 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  • Withdrawn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
HanHeng
Generic Name
General-purpose absorbent tip applicator/swab, single-use
Device Name
Disposable sampling swab
Model / Reference
A-series, A-011
Primary DI / UDI-DI
06973697810112
Basic UDI-DI
697369781001QQ
FDA Product Code
KXG
EMDN Code
A1101 Sample collection neutral swabs
GMDN Term
General-purpose absorbent tip applicator/swab, single-use
Device Class
Class I
Regulation Number
880.6025
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000018784
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Jiangsu HanHeng Medical Technology Co., Ltd

See all devices from Jiangsu HanHeng Medical Technology Co., Ltd →

Properties

  • Sterile
  • 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