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Wireless SpO2 3.0 Module (Networks 1-5)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803192771
Identity
- Trade Name
- Wireless SpO2 3.0 Module (Networks 1-5) EUDAMEDExpression MR Wireless SPO2 Patient module (Gen 3) 1-5 FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- Expression MR400 MRI Patient Monitor Sys EUDAMED3rd-Generation wireless SpO2 module for Expression MRI patient monitors (Networks 1-5). FDA UDI
- Model / Reference
- 989803192771 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
- 00884838055025 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838055025 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
- Germany EUDAMED
- Commercial Distribution
- Not 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 Invivo, a division of Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838055025 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 91bfd2a9-9049-4e32-9135-b17e3f781686 61 fields · synced Oct 7, 2026
- FDA UDI 80b34ec2-5bcf-431e-bcac-9768d0ee62b5 37 fields · synced May 22, 2026