Aselsan Heartline
by Ritim Grup Tibbi Cihazlar Elektronik Sanayi Ve Ticaret Anonim Sirketi 40 variants
Ref 6515-8444-0018Model AED-6515-8444-0018
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08682943410171 08682943410171 | Date23 May 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Aselsan Heartline AED Yarı Otomatik – Kapaklı – Ekranlı – RF Modül
- Model / Reference
- AED-6515-8444-0018, 6515-8444-0018
- Primary DI / UDI-DI
- 08682943410171
- Basic UDI-DI
- B-08682943410171
- EMDN Code
- Z12030501 Semi-automatic defibrillators
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000038675
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Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No