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Surgical Tape

by Shandong Xiaokang Biotechnology Co., Ltd. China EUDAMEDGUDID

Ref N/AModel XK-A, XK-B, XK-C, XK-D, XK-E, XK-F

Product code KGXEMDN M03030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16941562310019 UDI-DIDate8 May 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number69415623Tape01AN Basic UDI-DIDate5 Dec 2024RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Xiaokang Surgical Tape
Generic Name
Adhesive bandage
Device Name
Surgical Tape
Model / Reference
XK-A EUDAMED
XK-B EUDAMED
XK-C EUDAMED
XK-D EUDAMED
XK-E EUDAMED
XK-F EUDAMED
N/A EUDAMED
XK- A GUDID
Primary DI / UDI-DI
16941562310019
Basic UDI-DI
69415623Tape01AN
FDA Product Code
KGX
EMDN Code
M03030199 Elastic fixing bandages - other
GMDN Term
Adhesive bandage
Device Class
Class I
Regulation Number
880.5240
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
XK-A, XK-B, XK-C, XK-D, XK-E, XK-F
N/A
GUDID
XK- A

Manufacturer details

EUDAMED SRN
CN-MF-000011678
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Xiaokang Biotechnology Co., Ltd.

See all devices from Shandong Xiaokang Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (20)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 40289e12-fdd9-40a0-a615-c84a667ceb06 61 fields · synced 22 Oct 2026
  • FDA UDI 640309c6-ac70-44b6-a73b-657ae52eab31 32 fields · synced 23 Oct 2026