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Q-Rip Belt To Controller Cable For Alice
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0573A
Identity
- Trade Name
- Q-RIP BELT TO CONTROLLER CABLE FOR ALICE EUDAMEDQ-RIP to Belt Controller Cable for Alice FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Respiratory Effort Sensors EUDAMEDCable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
- Model / Reference
- 0573A EUDAMEDFDA UDI
- Description
- Cable for the Q-RIP™ Respiratory Effort System™ which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier. FDA UDI
Identifiers
- Catalog Number
- 0573A FDA UDI
- Primary DI / UDI-DI
- B1400573A0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140EffortFU EUDAMED
- Direct Marketing DI
- B1400573A0 EUDAMED
- 510(k) Number
- K001743 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Q-Rip Belt To Controller Cable For Alice by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B140EffortFU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 64e5537d-a4f7-414f-9abb-27a26e988a28 61 fields · synced Oct 6, 2026
- FDA UDI 6e013a85-bef2-4232-9d2d-cd908bb4d1a0 37 fields · synced May 30, 2026