Identity
- Trade Name
- EFFICIA 3/5 ECG TRUNK CABLE, AAMI/IEC EUDAMED
- Device Name
- Efficia ECG Cables and Leadsets EUDAMED
- Model / Reference
- 989803160641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838047884 EUDAMED
- Basic UDI-DI
- 0884838BM550T2 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Efficia 3/5 Ecg Trunk Cable, Aami/Iec by Philips Medical Systems — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM550T2 | Class I | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED c30b940d-7a84-499b-bc30-030f1cd4bac6 61 fields · synced Jul 9, 2026