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IntelliBridge EC40/80
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 865056Model IntelliBridge Hub
Identity
- Trade Name
- IntelliBridge EC40/80 EUDAMEDIntelliBridge FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- IntelliBridge Hub EUDAMEDIntelliBridge EC40/80 FDA UDI
- Model / Reference
- IntelliBridge Hub EUDAMED865056 EUDAMEDIntelliBridge EC40/80 FDA UDI
- Description
- IntelliBridge EC40/80 FDA UDI
Identifiers
- Catalog Number
- 865056 FDA UDI
- Primary DI / UDI-DI
- 00884838090811 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM651T9 EUDAMED
- Direct Marketing DI
- 00884838090811 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Austria 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
IntelliBridge EC40/80 by Philips Medical Systems — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093177 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM651T9 | Class I | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 20cd6abf-cc5b-4fab-a33c-ab1ad9566101 61 fields · synced Jul 25, 2026
- FDA UDI eb58bd0e-f776-412d-8b17-ec82a5fca662 37 fields · synced May 30, 2026
- FDA 510(k) K093177 1 fields · synced May 18, 2026