Identity
- Trade Name
- Upgrade Marlin to R5.7 EUDAMED
- Device Name
- Marlin 1.5T EUDAMED
- Model / Reference
- 782126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838103597 EUDAMED
- Basic UDI-DI
- 0884838BM938TY EUDAMED
- Direct Marketing DI
- 00884838103597 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
- Sweden 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
Upgrade Marlin to R5.7 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 | 0884838BM938TY | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (1)
- EUDAMED 99837dc6-8a89-4989-92c5-66d21b7d62c0 61 fields · synced Oct 6, 2026