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Enema Kit

by Ningbo Albert Novosino Co., Ltd. 8 variants

Ref 4LModel 0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml

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

CE MDR

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
United StatesGUDID listing GUDID Number06971919467229 UDI-DI Date28 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697191946EK4H Basic UDI-DI 06971919467229UDI-DIDate15 Apr 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Enema Kit EUDAMED
TopQuaFocus GUDID
Generic Name
Gravity enema set
Model / Reference
0.5L, 1L, 1.5L, 1.75L, 2L, 2.5L, 3L, 3.5L, 4L, 450ml
Primary DI / UDI-DI
06971919467229
Basic UDI-DI
697191946EK4H
FDA Product Code
FCE
EMDN Code
A020299 Reusable syringes - other
GMDN Term
Gravity enema set
Device Class
Class I
Regulation Number
876.5210
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000008571
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Ningbo Albert Novosino Co., Ltd.

See all devices from Ningbo Albert Novosino Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • 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