Identity
- Trade Name
- 7-Wire Lead Set for 12-lead use IEC EUDAMEDHeartStart FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Cables and Cable Accessories EUDAMEDAdditional 7-Wire Lead Set for 12 Lead (IEC) FDA UDI
- Model / Reference
- M3529A EUDAMED7-Wire Lead Set for 12-lead use IEC FDA UDI
- Description
- Additional 7-Wire Lead Set for 12 Lead (IEC) FDA UDI
Identifiers
- Catalog Number
- M3529A FDA UDI
- Primary DI / UDI-DI
- 00884838002784 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM483TC EUDAMED
- FDA Product Code
- DRO FDA UDIMKJ FDA UDI
- EMDN Code
- Z12030585 DEFIBRILLATORS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5550 FDA UDI870.5310 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
7-Wire Lead Set for 12-lead use IEC by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM483TC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 6bcea72b-3918-4734-bd42-91a5b4066d01 61 fields · synced Jul 12, 2026
- FDA UDI 62572081-31de-4830-a595-884ce55cc495 37 fields · synced May 29, 2026