Identity
- Trade Name
- External Paddles Water Resistant EUDAMEDHeartStart FDA UDI
- Generic Name
- External defibrillation electrode, adult, reusable FDA UDI
- Device Name
- External Paddles & External Paddle Accs EUDAMEDExternal Paddles - Water Resistant FDA UDI
- Model / Reference
- M3543A EUDAMEDExternal Paddles Water Resistant FDA UDI
- Description
- External Paddles - Water Resistant FDA UDI
Identifiers
- Catalog Number
- M3543A FDA UDI
- Primary DI / UDI-DI
- 20884838015245 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838015245 EUDAMED
- FDA Product Code
- MKJ FDA UDI
- EMDN Code
- Z12030580 DEFIBRILLATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- External defibrillation electrode, adult, reusable 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
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
External Paddles Water Resistant 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-20884838015245 | 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-000002321
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (3)
- EUDAMED 42b1f4b8-7950-43c4-97dc-3f478db442bd 61 fields · synced Sep 30, 2026
- FDA UDI 0839769c-43f8-4cca-857e-be24961d2cd2 34 fields · synced May 30, 2026
- EUDAMED 477236cb-0530-47d9-942e-0a6ec21707ff 61 fields · synced Jun 18, 2026