Automatic External Defibrillator
by Ambulanc (Shenzhen) Tech. Co., Ltd. China EUDAMED
Ref LS1 Pro Fully AutomaticModel i7、i7 Plus、i9、i9 Plus、LS1 Semi Automatic、 LS1 Pro Semi Automatic、 LS1 Fully Automatic、 LS1 Pro Fully Automatic
EMDN Z12030503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69706581400199X | Date22 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 779600 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 15 Jul 2026
- Expires
- 14 Jul 2031
Specification
- Model / Reference
- i7、i7 Plus、i9、i9 Plus、LS1 Semi Automatic、 LS1 Pro Semi Automatic、 LS1 Fully Automatic、 LS1 Pro Fully Automatic, LS1 Pro Fully Automatic
- Primary DI / UDI-DI
- 06970658143128
- Basic UDI-DI
- 69706581400199X
- Direct Marketing DI
- 06970658143128
- EMDN Code
- Z12030503 Automatic defibrillators
- Device Class
- Class III
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000010435
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ambulanc(Shenzhen)Tech.Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED d75e3ef3-0ec3-4db4-a36c-0bc32f954b31