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Needle Hub Assembly

by Philips Medical Systems Nederland B.V.

Ref 989603203604

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

CE MDR

Valid until

1 May 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

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
European UnionCE/MDR EUDAMED Number2243595CE04 Date24 Sep 2026IssuedStatusActive expires 1 May 2030
United StatesGUDID listing GUDID Number00884838118584 UDI-DI Date18 Jul 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE04 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    24 Sep 2026
    Expires
    1 May 2030
    Reason
    Other

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  • Withdrawn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
Needle Hub Assembly EUDAMED
Philips GUDID
Generic Name
Needle guide, single-use
Device Name
Breast Biopsy Devices PMS Sterile
Model / Ref / Catalog
989603203604, Needle Hub Assembly
Primary DI / UDI-DI
00884838118584
Basic UDI-DI
0884838BM841TG
FDA Product Code
GDF
EMDN Code
A018002 Needle guides
GMDN Term
Needle guide, single-use
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
989603203604
GUDID
Needle Hub Assembly

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No