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BlueSeal SE

by Philips Medical Systems Nederland B.V. Netherlands EUDAMED510(k)GUDID

Ref 782193, 782228, 782216510(k) K253648

Product code LNHEMDN Z11050104,Z11050105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243595CE01 Date24 Sep 2026IssuedStatusActive expires 1 May 2030
United StatesGUDID listing GUDID Number00884838128415 UDI-DIDate7 Apr 2026ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK253648 Date23 Feb 2026ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    24 Sep 2026
    Expires
    1 May 2030
    Reason
    Add device or group

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
BlueSeal SE EUDAMED
Mr 5300 EUDAMEDGUDID
Ingenia Elition S EUDAMED
Ingenia GUDID
Generic Name
Full-body MRI system, superconducting magnet
Device Name
Magnetic Resonance Imaging Systems
Model / Ref / Catalog
782193, 782228, 782216, MR 5300, BlueSeal SE, Ingenia Elition S
Primary DI / UDI-DI
00884838128415, 00884838129009, 00884838128200
Basic UDI-DI
0884838BM697TZ
Direct Marketing DI
00884838128415
00884838129009
00884838128200
510(k) Number
FDA Product Code
LNH, LNI
EMDN Code
Z11050104,Z11050105, Z11050104, Z11050105
GMDN Term
Full-body MRI system, superconducting magnet
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1000
Market of Registration
Netherlands
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
782193
782228
782216
510(k)
n/a
GUDID
MR 5300
BlueSeal SE
Ingenia Elition S
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Related devices

Category: Full-body MRI system, superconducting magnet

Other devices from Philips Medical Systems Nederland B.V.

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

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
Other properties (22)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (7)

  • EUDAMED 698231e6-8d1d-486e-9d38-24999a0bd3ec 61 fields · synced 24 Oct 2026
  • FDA 510(k) K253648 24 fields · synced 18 May 2026
  • EUDAMED 00884838129009|0884838BM697TZ 61 fields · synced 30 Jul 2026
  • EUDAMED 00884838128200|0884838BM697TZ 61 fields · synced 30 Jul 2026
  • FDA UDI fa74eb9f-4040-40ea-9559-3953b717f7c9 35 fields · synced 23 Oct 2026
  • FDA UDI f5c20404-95ad-4230-be59-7ee4a935e7c9 35 fields · synced 23 Oct 2026
  • FDA UDI ea079e46-9213-42a6-8c95-af216d3cf3c3 35 fields · synced 23 Oct 2026