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Philips NightBalance Mobile App, Android
EUDAMEDClass IIa (EU MDR)
Ref 1142207Model NightBalance
Identity
- Trade Name
- Philips NightBalance Mobile App, Android EUDAMED
- Model / Reference
- NightBalance EUDAMED1142207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959419629 EUDAMED
- Basic UDI-DI
- B-00606959419629 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
Philips NightBalance Mobile App, Android 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-00606959419629 | 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 4849e4bf-1993-4064-ad9b-9e73a4022b1f 61 fields · synced Jun 17, 2026
- EUDAMED 642e0b18-65b0-4194-8c9f-ded86ab56d4b 61 fields · synced Jun 11, 2026