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Easy Flush

by SPM Medicare Pvt. Ltd. India EUDAMEDGUDID

Ref 1BO7R5SModel 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Ribbon pack (Sterile Fluid Path) and 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Blister pack, (Externally Sterile)

Product code NGTEMDN A02010701

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000323461 Date31 Jul 2026IssuedStatusActive expires 8 Aug 2029
United StatesGUDID listing GUDID Number08904379807937 UDI-DIDate7 Mar 2026ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000323461 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    31 Jul 2026
    Expires
    8 Aug 2029

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device Name
Flush Syringe (Prefilled 0.9 % saline solution)
Model / Ref / Catalog
3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Ribbon pack (Sterile Fluid Path) and 3ml, 100ml-Blister pack, (Externally Sterile), 1BO7R5S, 5 ml (Sterile Fluid Path)
Primary DI / UDI-DI
08904379807937
Basic UDI-DI
89043798FSHEYE
510(k) Number
FDA Product Code
NGT
EMDN Code
A02010701 Prefilled syringes with sterile physiological solution
GMDN Term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
880.5200
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IN-MF-000011829
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Spm Medicare Pvt., Ltd.

See all devices from Spm Medicare Pvt., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (15)
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (2)

  • EUDAMED ab933c10-8959-4789-b727-c688a207186d 61 fields · synced 23 Oct 2026
  • FDA UDI 297e972d-1093-4a64-818a-f4a71301d846 38 fields · synced 23 Oct 2026