Q-RIP Starter Kit
by BRAEBON Medical Corporation Canada EUDAMEDGUDID
Ref 0570.2
Product code BZQEMDN Z12100580
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++B140EffortFU | Date7 Mar 2024 | StatusActive |
| United States | GUDID listing GUDID | NumberB140057020 | Date22 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Q-RIP Starter Kit EUDAMEDBRAEBON Q-RIP Starter Kit GUDID
- Generic Name
- Pneumograph
- Device Name
- Respiratory Effort Sensors
- Model / Ref / Catalog
- 0570.2
- Primary DI / UDI-DI
- B140057020
- Basic UDI-DI
- ++B140EffortFU
- 510(k) Number
- FDA Product Code
- BZQ
- EMDN Code
- Z12100580 Polysomnography instruments - hardware accessories
- GMDN Term
- Pneumograph
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 868.2375
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CA-MF-000002190
- Authorised representative
- AR Experts B.V. NL-AR-000023989
Other devices from Braebon Medical Corporation
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Single Use: 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
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 211b8d18-08a4-4446-8730-c1c88ed434e3
- FDA UDI 28d3871b-aceb-42c3-a5ba-7c86c863355b