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Awi 209-03

by Apex (Guangzhou) Tools & Orthopedics Co. 2 variants

Awi 209-03 is a Class II device made by Apex (Guangzhou) Tools & Orthopedics Co., registered in EUDAMED and listed in FDA GUDID since 3 Mar 2020 (UDI-DI 06957277200692), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06957277200692 UDI-DI Date3 Mar 2020ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 06957277200692 listed 3 Mar 2020 Listed

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  • Withdrawn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
Awi
Generic name
Disposable surgical irrigation/aspiration system
Model / reference
209-03
Primary DI / UDI-DI
06957277200692
FDA product code
FQH
GMDN term
Disposable surgical irrigation/aspiration system
Device class
Class II
Regulation number
880.5475
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FQH (Lavage, Jet).

Other devices from Apex (Guangzhou) Tools & Orthopedics Co.

See all devices from Apex (Guangzhou) Tools & Orthopedics Co. →

Properties

  • Supplied sterile
  • Single use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)