Identity
- Trade Name
- 0395-2049 Interface Cable EUDAMED
- Device Name
- Fogg Patient Monitoring Cable EUDAMED
- Model / Reference
- 0395-2049:L78 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840416606577 EUDAMED
- Basic UDI-DI
- 8404166CBL001G7 EUDAMED
- Direct Marketing DI
- 00840416606577 EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
0395-2049 Interface Cable by Fogg System Company, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8404166CBL001G7 | Class I | Active |
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Manufacturer
- Manufacturer
- Fogg System Company, Inc.
- EUDAMED SRN
- US-MF-000040329
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 8d23a445-09ef-43ab-973e-94ccca6d17b3 61 fields · synced Jun 20, 2026