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Philips NightBalance, Refurbishment Kit, FR
EUDAMEDClass IIa (EU MDR)
Ref RPL2EU01FR
Identity
- Trade Name
- Philips NightBalance, Refurbishment Kit, FR EUDAMED
- Device Name
- NightBalance EUDAMED
- Model / Reference
- RPL2EU01FR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959419964 EUDAMED
- Basic UDI-DI
- B-00606959419964 EUDAMED
- EMDN Code
- Z12062402 POSITIONAL BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Philips NightBalance, Refurbishment Kit, FR 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-00606959419964 | 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 (1)
- EUDAMED 79ea2200-64e7-4052-a9df-e0096d5c0530 61 fields · synced Jun 18, 2026