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Philips NightBalance Mobile App, iOS
EUDAMEDClass IIa (EU MDR)
Ref 1142206Model NightBalance
Identity
- Trade Name
- Philips NightBalance Mobile App, iOS EUDAMED
- Model / Reference
- NightBalance EUDAMED1142206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959419612 EUDAMED
- Basic UDI-DI
- B-00606959419612 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, iOS 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-00606959419612 | 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 f1f1ad61-7130-42e1-a3b3-751f0a13d78c 61 fields · synced Jun 19, 2026
- EUDAMED 3ed49bed-3161-48f4-bf9a-3607c6520648 61 fields · synced Jun 19, 2026