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Double Valve Aspirator

by WomanCare Global, LLC United States EUDAMEDGUDID

Ref DVS-S10, DVS-SU Product code HHIEMDN Z12080299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0853615006DVSSTERILELH Basic UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10853615006366 UDI-DIDate17 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Double Valve Aspirator EUDAMED
Double Valve Aspirator, unsterile EUDAMED
WomanCare Global Double-Valve Aspirator GUDID
Generic Name
Abortion suction system collection bottle
Device Name
Double-Valve Aspirator
Model / Reference
DVS-S10, DVS-SU
Primary DI / UDI-DI
10853615006366, 00853615006253
Basic UDI-DI
0853615006DVSSTERILELH, 0853615006DVSNONSTERILE7K
Unit of Use DI
00853615006369
FDA Product Code
HHI
EMDN Code
Z12080299 Gynaecology and fertility treatment instruments - other
GMDN Term
Abortion suction system collection bottle
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.5070
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution
Size
Outer Diameter — 3.5 Inch
Length — 9.0 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
No
GUDID
No

Manufacturer details

EUDAMED SRN
US-MF-000042625
Authorised representative
Donawa Lifescience Consulting Srl IT-AR-000007785

Other devices from WomanCare Global, LLC

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDNoEUDAMEDGUDID
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 7ced1cfc-e02c-4c55-a41a-47c193d50886 61 fields · synced 22 Oct 2026
  • EUDAMED 00853615006253|0853615006DVSNONSTERILE7K 61 fields · synced 17 May 2026
  • FDA UDI 60b5237b-4c8a-4d3e-9e5e-862e5223682a 36 fields · synced 30 May 2026