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Endoclean EDKN-004006/004013/004014

by Changzhou Endoclean Medical Device Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06973141950302 UDI-DI Date28 Apr 2026ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Endoclean
Generic Name
Endoscope channel support kit
Model / Reference
EDKN-004006/004013/004014
Primary DI / UDI-DI
06973141950302
510(k) Number
FDA Product Code
ODC
GMDN Term
Endoscope channel support kit
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K232244)

Other devices from Changzhou Endoclean Medical Device Co., Ltd.

See all devices from Changzhou Endoclean Medical Device Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No