Identity
- Trade Name
- Short Standard ECG 2.0 Cable IEC EUDAMED
- Device Name
- Reusable Electrocardiographic Leads EUDAMED
- Model / Reference
- 989803185461 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838102415 EUDAMED
- Basic UDI-DI
- 0884838BM455T7 EUDAMED
- Direct Marketing DI
- 00884838102415 EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER 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
Short Standard ECG 2.0 Cable IEC by Invivo, a division of 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 | 0884838BM455T7 | Class I | Active |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (1)
- EUDAMED 9b78b152-417a-4817-b825-4b1a82a6e943 61 fields · synced Oct 7, 2026