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Dlr-8921

by Dolanvy (Suzhou) Medical Technology Co., Ltd.

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 Number06975854030029 UDI-DI Date17 Jun 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  • Withdrawn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
Dlr
Generic Name
Pelvic floor exercise biofeedback device, invasive
Model / Reference
DLR-8921
Primary DI / UDI-DI
06975854030029
510(k) Number
FDA Product Code
KPI
GMDN Term
Pelvic floor exercise biofeedback device, invasive
Device Class
Class II
Regulation Number
876.5320
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252831)

Other devices from Dolanvy (Suzhou) Medical Technology Co., Ltd.

See all devices from Dolanvy (Suzhou) Medical Technology Co., Ltd. →

Properties

  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

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