Identity
- Trade Name
- Wireless ECG 2.0 Module EUDAMEDExpression MR Wireless ECG Patient Module FDA UDI
- Generic Name
- Patient monitoring system module, electrocardiographic FDA UDI
- Device Name
- Wirelss Gating&Wirelss ECG/SpO2 Modules EUDAMEDROHS-compliant wireless ECG module for use with Expression monitors and wireless gating systems. FDA UDI
- Model / Reference
- 989803183661 EUDAMEDWireless ECG 2.0 Module FDA UDI
- Description
- ROHS-compliant wireless ECG module for use with Expression monitors and wireless gating systems. FDA UDI
Identifiers
- Catalog Number
- 989803183661 FDA UDI
- Primary DI / UDI-DI
- 00884838044678 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838044678 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
- Germany 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
No
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
Wireless ECG 2.0 Module 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-00884838044678 | 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 69ebb4b6-5a63-4c1a-aa4b-8ccdbc26f50d 61 fields · synced Oct 6, 2026
- FDA UDI 2e02c363-1881-4f3e-8b0e-38aed98b6360 36 fields · synced May 30, 2026