Identity
- Trade Name
- AC Power Module EUDAMEDHeartStart FDA UDI
- Generic Name
- Basic power supply, reusable FDA UDI
- Device Name
- Other Accessories EUDAMEDAC Power Module FDA UDI
- Model / Reference
- M3539A EUDAMEDAC Power Module FDA UDI
- Description
- AC Power Module FDA UDI
Identifiers
- Catalog Number
- M3539A FDA UDI
- Primary DI / UDI-DI
- 20884838015207 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838015207 EUDAMED
- FDA Product Code
- MKJ FDA UDIDRO FDA UDI
- EMDN Code
- Z12030580 DEFIBRILLATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic power supply, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 FDA UDI870.5550 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AC Power Module 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-20884838015207 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002128
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 035a6b88-91bd-45c5-a935-5c1ecd66c6c0 61 fields · synced Jul 9, 2026
- FDA UDI 497e8b5a-5922-4ab5-96c2-16307719a431 37 fields · synced May 30, 2026