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Limb Lead Set (Both AAMI and IEC)
EUDAMEDClass I (EU MDR)
Ref 989803151711Model Lead Set/Patient Cable/Lead Upgrade Kit
Identity
- Trade Name
- Limb Lead Set (Both AAMI and IEC) EUDAMED
- Device Name
- Lead Set/Patient Cable/Lead Upgrade Kit EUDAMED
- Model / Reference
- Lead Set/Patient Cable/Lead Upgrade Kit EUDAMED989803151711 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838117259 EUDAMED
- Basic UDI-DI
- 0884838BM1861N5 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES 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
Category: Electrocardiographic lead set, reusable
Limb Lead Set (Both AAMI and IEC) by Philips Medizin Systeme Böblingen GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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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 | 0884838BM1861N5 | Class I | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (1)
- EUDAMED c05b7b0c-b9ad-48eb-bda7-a7feda3392a7 61 fields · synced Oct 6, 2026