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Optiflow AA511

by Fisher & Paykel Healthcare, Inc.

Ref AA511

Optiflow AA511 is a medical device service rail clamp (EU MDR Class I; FDA Class I; FDA product code FOX, Stand, Infusion) made by Fisher & Paykel Healthcare, Inc., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 94200124RACACCMBP003E7) and listed in FDA GUDID since 6 Oct 2025 (UDI-DI 09420012480767), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200124RACACCMBP003E7 Basic UDI-DI 09420012480767UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420012480767 UDI-DI Date6 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 94200124RACACCMBP003E7 registered 6 Jul 2026 Active
  • FDA GUDID UDI-DI 09420012480767 listed 6 Oct 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09420012480767
  2. Registered EUDAMED 94200124RACACCMBP003E7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
F&P Optiflow EUDAMED
Optiflow GUDID
Generic name
Medical device service rail clamp
Device name
Mounting accessory
Model / Ref / Catalog
AA511
Primary DI / UDI-DI
09420012480767
Basic UDI-DI
94200124RACACCMBP003E7
Direct marketing DI
09420012480767
FDA product code
FOX
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Medical device service rail clamp
Device class
Class I
Regulation number
880.6990
EU registration type
Standard device
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Fisher & Paykel Healthcare, Inc.

See all devices from Fisher & Paykel Healthcare, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)