REANIBEX-300 AED SPANISH +IrDA sensor
Ref DIA2354A0000001Model Reanibex 300 / Reanibex 500
Active
CE MDR
Valid until
26 Mar 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1843604570E000000000002CS 08436045705730 | Date19 May 2026 | StatusActive |
Certificates
- 1000291267 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 12 Feb 2026
- Expires
- 26 Mar 2030
- Reason
- Other
- 1000291268 Active
Technical documentation EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 18 Feb 2026
- Expires
- 26 Mar 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- AED/Manual Defibrillator Monitor Defibrillator
- Model / Reference
- Reanibex 300 / Reanibex 500, DIA2354A0000001
- Primary DI / UDI-DI
- 08436045705730
- Basic UDI-DI
- 1843604570E000000000002CS
- Direct Marketing DI
- 08436045705730
- EMDN Code
- Z12030501 Semi-automatic defibrillators
- Device Class
- Class III
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- ES-MF-000004710
Other devices from Osatu Sociedad Cooperativa
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No