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Sunder Sd-K01

by Sunder Biomedical Tech. Co., Ltd. 5 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04711552761498 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sunder
Generic Name
Haemodialysis blood tubing set, single-use
Model / Reference
SD-K01
Primary DI / UDI-DI
04711552761498
510(k) Number
FDA Product Code
FJK
GMDN Term
Haemodialysis blood tubing set, single-use
Device Class
Class II
Regulation Number
876.5820
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Related devices

Cleared under the same submission (K014140)

Other devices from Sunder Biomedical Tech. Co., Ltd.

See all devices from Sunder Biomedical Tech. Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

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