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RocaFlow II - Simple Chamber RF0101

by Promepla

RocaFlow II - Simple Chamber RF0101 is a Class II device made by Promepla, listed in FDA GUDID since 14 Sep 2016 (UDI-DI 03700512955160), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700512955160 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
RocaFlow II - Simple Chamber
Generic name
Endoscopic irrigation/aspiration pump
Model / Ref / Catalog
RF0101
Primary DI / UDI-DI
03700512955160
FDA product code
OCX
GMDN term
Endoscopic irrigation/aspiration pump
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code OCX (Endoscopic Irrigation/Suction System).

Other devices from Promepla

See all devices from Promepla →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)