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smart-sync

by northh medical GmbH United States EUDAMEDGUDID

Ref P01-SB-01 (Lot 06)Model P01-SB-01

Product code LNHEMDN Z1105018099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260675390042 UDI-DIDate14 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number426067539P01FK Basic UDI-DIDate1 Nov 2021RegisteredStatusActive

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: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
MRI system synchronizer
Model / Ref / Catalog
P01-SB-01, P01-SB-01 (Lot 06), P01-SB-01 (LOT: 6)
Primary DI / UDI-DI
04260675390042
Basic UDI-DI
426067539P01FK
Direct Marketing DI
04260675390042
510(k) Number
FDA Product Code
LNH
EMDN Code
Z1105018099 Magnetic resonance (mr) systems - hardware accessories - other
GMDN Term
MRI system synchronizer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
P01-SB-01
P01-SB-01 (Lot 06)
GUDID
P01-SB-01 (LOT: 6)
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005858

Other devices from Northh Medical GmbH

  • smart-sync

    Class IIa

  • smart-sync

    Class IIa

  • smart-sync

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 16da8a11-13ab-4b35-9ab8-e14fc8b1496f 61 fields · synced 23 Oct 2026
  • FDA UDI 0da1daed-b858-44c9-a584-50912227dedd 36 fields · synced 23 Oct 2026