Identity
- Trade Name
- Long 10-lead Patient Cable IEC EUDAMED
- Device Name
- TC 10, TC20, TC30, TC50, TC70 lead sets EUDAMED
- Model / Reference
- 989803184941 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838048096 EUDAMED
- Basic UDI-DI
- 0884838BM511SQ EUDAMED
- EMDN Code
- Z12050301 GENERAL PURPOSE ELECTROCARDIOGRAPHS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Long 10-lead Patient Cable 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 | 0884838BM511SQ | 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 4e2463d9-b2f7-433b-9385-7e388b5d1fc8 61 fields · synced Jun 18, 2026