Identity
- Trade Name
- BlueSeal XE EUDAMED
- Device Name
- Magnetic Resonance Imaging Systems EUDAMED
- Model / Reference
- 782186 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838125704 EUDAMED
- Basic UDI-DI
- 0884838BM697TZ EUDAMED
- Direct Marketing DI
- 00884838125704 EUDAMED
- EMDN Code
- Z11050104 CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Full-body MRI system, superconducting magnet
BlueSeal XE by Philips Medical Systems Nederland B.V. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Full-body MRI system, superconducting magnet.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM697TZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (1)
- EUDAMED 6c9878e8-e2a7-41dd-a6fb-deaab94c6aaa 61 fields · synced Sep 18, 2026