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Surgical Tape

by Shandong Xiaokang Biotechnology Co., Ltd. 12 variants

Model XK-A, XK-B, XK-C, XK-D, XK-E, XK-F

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
United StatesGUDID listing GUDID Number06941562310050 UDI-DI Date8 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69415623Tape01AN Basic UDI-DI 06941562310050UDI-DIDate5 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier 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  • Withdrawn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
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
XK- E GUDID
Primary DI / UDI-DI
06941562310050
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
EU market of registration
Belgium
GUDID distribution status
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
GUDID
XK- E

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

  • 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