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Hygitech Hy-12017

by Hygitech

Ref HY-12017Model Aspiration System

Hygitech Hy-12017 is a device classified as Class IIa in the EU and Class I in the US made by Hygitech, registered in EUDAMED on 29 Jan 2026 (Basic UDI-DI 361514H3ASPI181RG) with CE/MDR certificate 0425-MDR-030221-00 valid until 11 Apr 2028 and listed in FDA GUDID since 24 Nov 2020 (UDI-DI 03615140001878), active as of 22 Oct 2026.

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

CE MDR

Valid until

11 Apr 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ICIM S.P.A.

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0425-MDR-030221-00 Date30 Sep 2026IssuedStatusActive expires 11 Apr 2028
United StatesGUDID listing GUDID Number03615140001878 UDI-DI Date24 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361514H3ASPI181RG registered 29 Jan 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03615140001878 listed 24 Nov 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030221-00 Active

    Quality assurance EU MDR

    Certifier
    ICIM S.P.A. 0425
    Issued
    30 Sep 2026
    Expires
    11 Apr 2028

Timeline

4 dated events

  1. Listed FDA GUDID 03615140001878
  2. Registered EUDAMED 361514H3ASPI181RG
  3. Certificate issued EUDAMED 0425-MDR-030221-00
  4. Certificate expires EUDAMED 0425-MDR-030221-00

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  • Withdrawn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
Surgical aspiration with cannula EUDAMED
Hygitech GUDID
Generic name
Airway suction catheter
Model / Ref / Catalog
HY-12017, Aspiration System
Primary DI / UDI-DI
03615140001878
Basic UDI-DI
361514H3ASPI181RG
FDA product code
EFS
EMDN code
A06010103 Cannulas and tips for aspiration and irrigation, single-use
GMDN term
Airway suction catheter
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6510
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Airway suction catheter

Similar devices in this category

Other devices filed under CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE.

Other devices from Hygitech

See all devices from Hygitech →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)