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Positioning System FPRMC00036

by Uc-Care Ltd

Positioning System FPRMC00036 is an urinary catheter holder (FDA Class II; FDA product code EZL, Catheter, Retention Type, Balloon) made by Uc-Care Ltd, cleared under FDA 510(k) K082919 on 27 Oct 2008 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 07290016936247), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K082919

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016936247 UDI-DI Date15 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082919 Date27 Oct 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082919 decided 27 Oct 2008 Active
  • FDA GUDID UDI-DI 07290016936247 listed 15 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082919
  2. Listed FDA GUDID 07290016936247

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Positioning System
Generic name
Urinary catheter holder, sterile
Model / Ref / Catalog
FPRMC00036
Primary DI / UDI-DI
07290016936247
510(k) Number
FDA product code
EZL
GMDN term
Urinary catheter holder, sterile
Device class
Class II
Regulation number
876.5130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Urinary catheter holder, sterile

Similar devices

Other devices filed under FDA product code EZL (Catheter, Retention Type, Balloon).

Other devices from Uc-Care Ltd

See all devices from Uc-Care Ltd →

Properties

  • Supplied sterile
  • Serial number
Other properties (13, all answered No)