Identity
- Trade Name
- Upgrades dStream to R11 EUDAMEDMR 5300, MR 7700 & Ingenia FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- Magnetic Resonance Imaging Systems EUDAMEDUpgrades dStream to R11 FDA UDI
- Model / Reference
- 782142 EUDAMEDUpgrades dStream to R11 FDA UDI
- Description
- Upgrades dStream to R11 FDA UDI
Identifiers
- Catalog Number
- 782142 FDA UDI
- Primary DI / UDI-DI
- 00884838108653 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM697TZ EUDAMED
- Direct Marketing DI
- 00884838108653 EUDAMED
- 510(k) Number
- K213583 FDA UDI
- FDA Product Code
- LNH FDA UDILNI FDA UDI
- EMDN Code
- Z11050104,Z11050105 EUDAMED
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Upgrades dStream to R11 by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM697TZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED 64289ff6-24c6-4e2e-8f69-ec09d7e04dca 61 fields · synced Oct 6, 2026
- FDA UDI c9df5b2c-56cb-45e5-8411-fa640cb12095 36 fields · synced May 30, 2026