Skip to content

Microaire

by Apex (Suzhou) Medical Products Company 3 variants

Ref 201-03-00

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-16972130470132 Basic UDI-DI 16972130470132UDI-DIDate23 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number16972130470132 UDI-DI Date24 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Disposable surgical irrigation/aspiration system
Device Name
Disposable Pulse Lavage
Model / Reference
201-03-00
Description
Disposable Pulse Lavage Knee Kit
Primary DI / UDI-DI
16972130470132
Basic UDI-DI
B-16972130470132
FDA Product Code
FQH
EMDN Code
A03040299 Irrigation kits, single-use - other
GMDN Term
Disposable surgical irrigation/aspiration system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5475
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000031975
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Apex (Suzhou) Medical Products Company

See all devices from Apex (Suzhou) Medical Products Company →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No