Identity
- Trade Name
- NightBalance EUDAMED
- Model / Reference
- NightBalance EUDAMED1145658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959060357 EUDAMED
- Basic UDI-DI
- B-00606959060357 EUDAMED
- EMDN Code
- Z12062402 POSITIONAL BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NightBalance by Respironics, Inc. — 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-00606959060357 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 07bcb738-6dbb-4e3a-a12c-01d4e116680a 61 fields · synced Jun 18, 2026
- EUDAMED 9f71515d-f8b8-4d68-93d8-07cbeeb83ed6 61 fields · synced Jun 18, 2026