Identity
- Trade Name
- Upgrades dStream to R12 EUDAMED
- Device Name
- Magnetic Resonance Imaging Systems EUDAMED
- Model / Reference
- 782161 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838115729 EUDAMED
- Basic UDI-DI
- 0884838BM697TZ EUDAMED
- Direct Marketing DI
- 00884838115729 EUDAMED
- EMDN Code
- Z11050104,Z11050105 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
Upgrades dStream to R12 by Philips Medical Systems Nederland B.V. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 57ed0192-aee8-4341-b9c1-f2d07c6cb23f 61 fields · synced Oct 6, 2026