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Hph-1400TS Hemoconcentr

by Medica S.p.A.

Ref 93024-125

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

CE MDR

Valid until

31 May 2028

CE MDR certificate

FDA recalls

None ongoing

1 closed

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803377232HMC-SET-ETO-Z8 Basic UDI-DI 08056992333611UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056992333611 UDI-DI Date1 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00048-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    16 Apr 2026
    Expires
    31 May 2028

Recalls

1 recall · FDA

    • Terminated Z-2735-2015 FDA Class II initiated 18 Aug 2015

    Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

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  • Withdrawn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
Hph-1400TS Hemoconcentr EUDAMED
Hph-1400TS Hemoconcentrator GUDID
Generic Name
Haemoconcentrator
Device Name
Sets for Hemoconcentration Devices
Model / Ref / Catalog
93024-125, 04
Primary DI / UDI-DI
08056992333611
Basic UDI-DI
803377232HMC-SET-ETO-Z8
510(k) Number
FDA Product Code
KDI
EMDN Code
C03010101 Extracorporeal circulation circuits
GMDN Term
Haemoconcentrator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5860
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
93024-125
GUDID
04
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000025691

Other devices from Medica S.p.A.

See all devices from Medica S.p.A. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No