Nox RIP Belts Disposable - Large - 20 sets
by Nox Medical Iceland EUDAMEDGUDID
Ref 551040
Product code MNREMDN Z12100585
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number1569431111NOX_RIPBELTS6W | Date18 Nov 2021 | StatusActive |
| United States | GUDID listing GUDID | Number15694311110187 | Date16 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Nox RIP Belts Disposable - Large - 20 sets EUDAMEDNox RIP Belts Disposable Large GUDID
- Generic Name
- Polysomnograph
- Device Name
- Nox RIP Belts Disposable
- Model / Ref / Catalog
- 551040, NOX-RIPDL20
- Primary DI / UDI-DI
- 15694311110187
- Basic UDI-DI
- 1569431111NOX_RIPBELTS6W
- Unit of Use DI
- 15694311110859
- 510(k) Number
- FDA Product Code
- MNR
- EMDN Code
- Z12100585 Polysomnography instruments - consumables
- GMDN Term
- Polysomnograph
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 868.2375
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 551040 | NOX-RIPDL20 |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- IS-MF-000000950
Other devices from Nox Medical
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED c3d467fb-03f3-4418-a40d-d7c07ec34efd
- FDA UDI e3a59066-7cf1-4bb0-8dd5-3fc6e4def8eb