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ECG 5 lead Grabber, AAMI + SpO2, SPU, Tele
EUDAMEDClass IIb (EU MDR)
Ref 989803172051Model Pulse oximeters with ECG leads
Identity
- Trade Name
- ECG 5 lead Grabber, AAMI + SpO2,SPU,Tele EUDAMED
- Device Name
- Pulse oximeters with ECG leads EUDAMED
- Model / Reference
- Pulse oximeters with ECG leads EUDAMED989803172051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20884838119769 EUDAMED
- Basic UDI-DI
- 0884838BM1911MT EUDAMED
- Unit of Use DI
- 00884838013506 EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb 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
ECG 5 lead Grabber, AAMI + SpO2, SPU, Tele by Philips Medical Systems — Class IIb — 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 | 0884838BM1911MT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (1)
- EUDAMED 8aa3d617-6d76-4813-9571-b5ed61b9d27e 61 fields · synced Jun 19, 2026