Identity
- Trade Name
- Heartstart HS1 EUDAMEDHeartStart FDA UDI
- Generic Name
- Non-rechargeable public semi-automated external defibrillator FDA UDI
- Device Name
- HeartStart HS1 Defibrillator and Accs. EUDAMEDHeartStart HS1 Defibrillator FDA UDI
- Model / Reference
- M5066A EUDAMEDHeartstart HS1 FDA UDI
- Description
- HeartStart HS1 Defibrillator FDA UDI
Identifiers
- Catalog Number
- M5066A FDA UDI
- Primary DI / UDI-DI
- 00884838075849 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838075849 EUDAMED
- FDA Product Code
- NSA FDA UDI
- EMDN Code
- Z12030501 SEMI-AUTOMATIC DEFIBRILLATORS EUDAMED
- GMDN Term
- Non-rechargeable public semi-automated external defibrillator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Heartstart HS1 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-00884838075849 | 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 2ecc6d53-47da-4098-8fd2-03ba857b51c9 61 fields · synced Aug 2, 2026
- FDA UDI 2ca640e5-0bf8-4fc5-9d25-c94264e2b320 36 fields · synced May 30, 2026