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Rectal Syringe

by Ningbo Albert Novosino Co., Ltd. China EUDAMEDGUDID

Ref 320mlModel 8ml, 25ml, 27ml, 40ml, 52ml, 65ml, 85ml, 89ml, 90ml, 95ml, 102ml, 115ml, 120ml, 143ml, 160ml, 165ml, 200ml, 205ml, 210ml, 216ml, 220ml, 224ml, 225ml, 275ml, 320ml, 347ml, 350ml, 355ml, 365ml, 420ml, 450ml, 483ml, 1oz,2oz, 3oz, 4oz, 5oz, 6oz, 7oz, 8oz Product code KYZEMDN A020299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971919467380 UDI-DIDate28 Aug 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number697191946RS68 Basic UDI-DIDate20 Apr 2024RegisteredStatusActive

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 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Rectal Syringe EUDAMED
TopQuaFocus GUDID
Generic Name
Manual enema device, reusable
Model / Reference
8ml, 25ml, 27ml, 40ml, 52ml, 65ml, 85ml, 89ml, 90ml, 95ml, 102ml, 115ml, 120ml, 143ml, 160ml, 165ml, 200ml, 205ml, 210ml, 216ml, 220ml, 224ml, 225ml, 275ml, 320ml, 347ml, 350ml, 355ml, 365ml, 420ml, 450ml, 483ml, 1oz, 2oz, 3oz, 4oz, 5oz, 6oz, 7oz, 8oz
Primary DI / UDI-DI
06971919467380, 06971919467373
Basic UDI-DI
697191946RS68
FDA Product Code
KYZ
EMDN Code
A020299 Reusable syringes - other
GMDN Term
Manual enema device, reusable
Device Class
Class I
Regulation Number
880.6960
Market of Registration
Austria
Commercial Distribution
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.

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (4)

  • EUDAMED 6645141d-9db1-42c5-a8e6-35747f4d1fb9 61 fields · synced 22 Oct 2026
  • FDA UDI 3827d331-6eb6-4adb-bb45-b9eac0be5c72 32 fields · synced 22 Oct 2026
  • FDA UDI b198739d-3618-4b64-90df-ced76081295a 32 fields · synced 22 Oct 2026
  • EUDAMED 06971919467373|697191946RS68 61 fields · synced 24 Oct 2026