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Rect. Pdl Electrodes Pepl M3535A-Gray
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref M4759A
Identity
- Trade Name
- Rect. Pdl Electrodes Pepl M3535A-Gray EUDAMEDHeartStart FDA UDI
- Generic Name
- Rechargeable professional automated external defibrillator FDA UDI
- Device Name
- External Paddle EUDAMEDRect. Pdl Electrode Repl. M3535A - Gray FDA UDI
- Model / Reference
- M4759A EUDAMEDRect. Pdl Electrodes Pepl M3535A-Gray FDA UDI
- Description
- Rect. Pdl Electrode Repl. M3535A - Gray FDA UDI
Identifiers
- Catalog Number
- M4759A FDA UDI
- Primary DI / UDI-DI
- 20884838015306 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838015306 EUDAMED
- FDA Product Code
- MKJ FDA UDIDRO FDA UDI
- EMDN Code
- Z12030580 DEFIBRILLATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Rechargeable professional automated external defibrillator 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
- 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
Rect. Pdl Electrodes Pepl M3535A-Gray 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-20884838015306 | 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 8ec23928-7c9f-4da0-a015-e7ee746bf597 61 fields · synced Jul 20, 2026
- FDA UDI b05a24d8-56fd-4e21-bc79-adc93dd0ce9f 36 fields · synced May 30, 2026