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HeartStart Intrepid
EUDAMEDClass IIb (EU MDR)
Ref 867172Model Intrepid Monitor/Defibrillator
Identity
- Trade Name
- HeartStart Intrepid EUDAMED
- Device Name
- Intrepid Monitor/Defibrillator EUDAMED
- Model / Reference
- Intrepid Monitor/Defibrillator EUDAMED867172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838087910 EUDAMED
- Basic UDI-DI
- B-00884838087910 EUDAMED
- EMDN Code
- Z12030599 DEFIBRILLATORS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HeartStart Intrepid by Philips Goldway (Shenzhen) Industrial Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838087910 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Goldway (Shenzhen) Industrial Inc.
- EUDAMED SRN
- CN-MF-000003921
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fcedac29-616a-4dfd-bb44-a08067c296cd 61 fields · synced Oct 8, 2026