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Wireless SpO2 3.0 Module (Networks 1-5)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803192771Model Wireless ECG/SpO2 Gen 3 Modules
Identity
- Trade Name
- Wireless SpO2 3.0 Module (Networks 1-5) EUDAMEDMR Patient Care Wireless SpO2 3.0 Module (Networks 1-5) FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- Wireless ECG/SpO2 Gen 3 Modules EUDAMED3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5). FDA UDI
- Model / Reference
- Wireless ECG/SpO2 Gen 3 Modules EUDAMED989803192771 EUDAMEDWireless SpO2 3.0 Module (Networks 1-5) FDA UDI
- Description
- 3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5). FDA UDI
Identifiers
- Catalog Number
- 989803192771 FDA UDI
- Primary DI / UDI-DI
- 00884838111448 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1080LZ EUDAMED
- Direct Marketing DI
- 00884838111448 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry 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 SpO2 3.0 Module (Networks 1-5) 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 e5c74b32-5ea5-4879-be56-af8c1714c107 61 fields · synced Jun 19, 2026
- FDA UDI 4bdb6e3c-d141-41a6-b4d4-9d4ba6df1ca3 35 fields · synced May 29, 2026