Identity
- Trade Name
- Philips NightBalance, IB EUDAMEDNightBalance FDA UDI
- Generic Name
- Behavioural therapy electrical stimulation system FDA UDI
- Device Name
- NightBalance EUDAMEDPhilips NightBalance, Iberia FDA UDI
- Model / Reference
- L2EU01IB EUDAMED00 FDA UDI
- Description
- Philips NightBalance, Iberia FDA UDI
Identifiers
- Catalog Number
- L2EU01IB FDA UDI
- Primary DI / UDI-DI
- 00606959059580 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959059580 EUDAMED
- 510(k) Number
- K180608 FDA UDI
- FDA Product Code
- MYB FDA UDI
- EMDN Code
- Z12062402 POSITIONAL BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Behavioural therapy electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Philips NightBalance, IB by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959059580 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 64240f66-d1f6-4a97-934a-6c64321187df 61 fields · synced Jun 18, 2026
- FDA UDI 8a2d87ca-3e4f-4d13-a4f9-b5e05ca7b544 37 fields · synced May 30, 2026