RTgo
by Philips Medical Systems Nederland B.V.
Ref 300015488621
Active
CE MDR
Valid until
1 May 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2243595CE01 | Date24 Sep 2026 | StatusActive |
Certificates
- 2243595CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 24 Sep 2026
- Expires
- 1 May 2030
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ingenia MR-RT software
- Model / Reference
- 300015488621
- Primary DI / UDI-DI
- 00884838128590
- Basic UDI-DI
- 0884838BM953TU
- Direct Marketing DI
- 00884838128590
- EMDN Code
- Z11050192 Magnetic resonance (MR) systems - medical device software
- Device Class
- Class IIb
- Special Device Type
- Software
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000001489
Other devices from Philips Medical Systems Nederland B.V.
See all devices from Philips Medical Systems Nederland B.V. →
Properties
Other properties (13)
- Sterile: 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