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Rollmed 2000ml

by Hangzhou Rollmed Co., ltd. 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number06941298160523 UDI-DI Date7 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rollmed
Generic Name
Wearable adult urine collection bag, open-ended
Model / Reference
2000ml
Primary DI / UDI-DI
06941298160523
FDA Product Code
FAQ
GMDN Term
Wearable adult urine collection bag, open-ended
Device Class
Class I
Regulation Number
876.5250
GUDID distribution status
In Commercial Distribution

Other devices from Hangzhou Rollmed Co., ltd.

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • 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
  • Serial Number: No
  • Expiration Date: No