Identity
- Trade Name
- MRx Lithium Ion Battery Module EUDAMEDHeartStart FDA UDI
- Generic Name
- Secondary battery FDA UDI
- Device Name
- HeartStart Batteries and Other General B EUDAMEDLithium Ion Battery Module FDA UDI
- Model / Reference
- M3538A EUDAMEDMRx Lithium Ion Battery Module FDA UDI
- Description
- Lithium Ion Battery Module FDA UDI
Identifiers
- Catalog Number
- M3538A FDA UDI
- Primary DI / UDI-DI
- 00884838002791 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838002791 EUDAMED
- FDA Product Code
- MKJ FDA UDI
- EMDN Code
- Z12030580 DEFIBRILLATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Secondary battery FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Market of Registration
- Belgium 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
MRx Lithium Ion Battery 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-00884838002791 | 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 Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 22fb2abd-3ebb-4b9c-be79-074cbcc7af3a 61 fields · synced Jun 18, 2026
- FDA UDI 2c73472d-664b-45fa-b653-6004038d6a3b 37 fields · synced May 30, 2026