Iris SR MRI
by Medico Srl
Ref PMIRISRMModel Iris SR MRI
Active
CE MDR
Valid until
28 Feb 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803292600PMIRISRM4W 08032926002198 | Date17 Jul 2026 | StatusActive |
Certificates
- 291/MDR Active
Technical documentation EU MDR
- Certifier
- IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. 0051
- Issued
- 22 Jun 2026
- Expires
- 28 Feb 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Iris SR MRI, PMIRISRM
- Primary DI / UDI-DI
- 08032926002198
- Basic UDI-DI
- 803292600PMIRISRM4W
- Direct Marketing DI
- 08032926002198
- EMDN Code
- J01010102 Implantable single chamber pacemakers with sensor (sr)
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000016800
Other devices from Medico Srl
Properties
Other properties (11)
- 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