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MedGyn Aspiration Kit with 5mm cannula

by Medgyn International, Inc

Ref 022515

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-M803022515 Basic UDI-DI M803022515UDI-DIDate6 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID NumberM803022515 UDI-DI Date8 Sep 2016ListedStatusListed 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  • Withdrawn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

Trade Name
MedGyn Aspiration Kit
Generic Name
Endometrial biopsy kit
Device Name
MedGyn Aspiration Kit with 5mm cannula
Model / Ref / Catalog
022515, 5mm Aspiration Kit
Primary DI / UDI-DI
M803022515
Basic UDI-DI
B-M803022515
FDA Product Code
BYY
EMDN Code
U089010 Uterine curettes, single-use
GMDN Term
Endometrial biopsy kit
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6740
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
022515
GUDID
5mm Aspiration Kit
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000031450
Authorised representative
Advena Limited MT-AR-000000234

From the manufacturer

Manufacturer's product page: Manual Vacuum Aspiration (MVA) Kit

Other devices from Medgyn International, Inc

See all devices from Medgyn International, Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No