Identity
- Trade Name
- Dx-Sleep Adapter EUDAMED
- Device Name
- Dx-Sleep Adapter EUDAMED
- Model / Reference
- Dx-400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00899994002172 EUDAMED
- Basic UDI-DI
- B-00899994002172 EUDAMED
- EMDN Code
- G030702 PH MONITORING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dx-Sleep Adapter by Respiratory Technology Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00899994002172 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respiratory Technology Corporation
- EUDAMED SRN
- US-MF-000009086
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ca8a73bb-2d35-41b1-9479-dc04deeac99e 61 fields · synced Jul 30, 2026