Identity
- Trade Name
- JFD7001HD EUDAMED
- Model / Reference
- SOMNO HD EUDAMEDNGD050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413410798 EUDAMED
- Basic UDI-DI
- 42504134HD59 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jfd7001hd by SOMNOmedics AG — Class IIa — 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 | 42504134HD59 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED f9176248-c1d1-41d6-a5d5-a1fd334e4a48 61 fields · synced Jul 18, 2026