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Easy Flush 10 ml (Sterile Fluid Path)

by Spm Medicare Private Limited

Ref 1BO7RXSModel 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Ribbon pack (Sterile Fluid Path) and 3ml, 5ml, 10ml, 20ml, 50ml, 100ml-Blister pack, (Externally Sterile)

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

CE MDR

Valid until

8 Aug 2029

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000323461 Date31 Jul 2026IssuedStatusActive expires 8 Aug 2029
United StatesGUDID listing GUDID Number08904379807975 UDI-DI Date7 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000323461 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    31 Jul 2026
    Expires
    8 Aug 2029

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Easy Flush
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), 1BO7RXS, 10 ml (Sterile Fluid Path)
Primary DI / UDI-DI
08904379807975
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
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 10 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K231724)

Other devices from Spm Medicare Private Limited

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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