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Wireless ECG 3.0 Module (Networks 6-10)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803194341
Identity
- Trade Name
- Wireless ECG 3.0 Module (Networks 6-10) EUDAMEDExpression MR Wireless ECG Patient Module (Gen 3) 6-10 FDA UDI
- Generic Name
- Patient monitoring system module, electrocardiographic FDA UDI
- Device Name
- Expression MR400 MRI Patient Monitor Sys EUDAMED3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 6-10). FDA UDI
- Model / Reference
- 989803194341 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
- 00884838055018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838055018 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
- Netherlands 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 ECG 3.0 Module (Networks 6-10) 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-00884838055018 | 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 45e1c379-f983-454c-9a53-c7064394a281 61 fields · synced Jun 18, 2026
- FDA UDI 6924338d-fe8b-40f4-9a94-6eb8b26c745a 37 fields · synced May 24, 2026