Identity
- Trade Name
- HeartStart Configure EUDAMEDPHILIPS HeartStart Configure FDA UDI
- Generic Name
- Emergency/ambulatory healthcare software FDA UDI
- Device Name
- Heartstart Configure Software EUDAMEDHeartStart Configure FDA UDI
- Model / Reference
- 861487 EUDAMEDHeartStart Configure FDA UDI
- Description
- HeartStart Configure FDA UDI
Identifiers
- Catalog Number
- 861487 FDA UDI
- Primary DI / UDI-DI
- 00884838041547 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838041547 EUDAMED
- FDA Product Code
- LDD FDA UDIMKJ FDA UDI
- EMDN Code
- Z12030582 DEFIBRILLATORS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Emergency/ambulatory healthcare software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5300 FDA UDI870.5310 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HeartStart Configure by Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838041547 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002128
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 5fc916d4-b714-49e9-9234-61c854903e94 61 fields · synced Jul 26, 2026
- FDA UDI 6ea6c893-34b2-43f7-b8b8-fe51a4a37ba3 34 fields · synced May 30, 2026