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External ADC Board
EUDAMEDFDA UDIClass I (EU MDR)
Ref SSC083AModel ADC-BoardRef SSC083
Identity
- Trade Name
- External ADC Board EUDAMEDExternal ADC Board - 8 Channels FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- ADC-Board EUDAMEDSSC083A EUDAMEDSSC083 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250413402052 EUDAMED04250413402045 EUDAMEDFDA UDI
- Basic UDI-DI
- 42504134ADCBC6 EUDAMED
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
External ADC Board by SOMNOmedics AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42504134ADCBC6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (3)
- EUDAMED 6ff5bcd9-8d65-4c94-9530-9e3239846f06 61 fields · synced Jul 26, 2026
- EUDAMED b5a7581f-cbe4-4ca8-93d7-939c2041d6dc 61 fields · synced May 18, 2026
- FDA UDI 87ddcf3d-617a-4b7a-bebb-db0101fe860c 32 fields · synced May 29, 2026