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Wireless ECG 3.0 Module (Networks 6-10)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803194341Model Wireless ECG/SpO2 Gen 3 Modules
Identity
- Trade Name
- Wireless ECG 3.0 Module (Networks 6-10) EUDAMEDMR Patient Care Wireless ECG 3.0 Module (Networks 6-10) FDA UDI
- Generic Name
- Patient monitoring system module, electrocardiographic FDA UDI
- Device Name
- Wireless ECG/SpO2 Gen 3 Modules EUDAMED3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10). FDA UDI
- Model / Reference
- Wireless ECG/SpO2 Gen 3 Modules EUDAMED989803194341 EUDAMEDWireless ECG 3.0 Module (Networks 6-10) FDA UDI
- Description
- 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10). FDA UDI
Identifiers
- Catalog Number
- 989803194341 FDA UDI
- Primary DI / UDI-DI
- 00884838111462 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1080LZ EUDAMED
- Direct Marketing DI
- 00884838111462 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, electrocardiographic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Wireless ECG 3.0 Module (Networks 6-10) by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1080LZ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED b94f3945-634a-4ecc-a0fe-de8749fa2e9a 61 fields · synced Oct 6, 2026
- FDA UDI 9d4faa42-197e-48d6-af7f-a882dc1b9db0 35 fields · synced May 29, 2026