Identity
- Trade Name
- IntelliBridge EC5 ID-Module EUDAMEDFDA UDI
- Generic Name
- Patient monitoring system module, interfacing FDA UDI
- Device Name
- IntelliBridge EC5 EUDAMEDThe IntelliBridge EC5 is a device identification module and port for connecting external medical devices with IntelliBridge EC10. FDA UDI
- Model / Reference
- 865114 EUDAMEDIntelliBridge EC5 ID-Module FDA UDI
- Description
- The IntelliBridge EC5 is a device identification module and port for connecting external medical devices with IntelliBridge EC10. FDA UDI
Identifiers
- Catalog Number
- 865114 FDA UDI
- Primary DI / UDI-DI
- 00884838015944 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838015944 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, interfacing FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 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
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
MR Unsafe FDA UDI
IntelliBridge EC5 ID-Module by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00884838015944 | 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 6aa4e414-3e50-4524-b53b-b0ebb7aadff0 61 fields · synced Jul 10, 2026
- FDA UDI 0099d67d-e7b7-4b21-a3c4-53eff7182e91 36 fields · synced May 29, 2026