Identity
- Trade Name
- RIP BELT FOR MEDIBYTE, LARGE EUDAMEDBRAEBON RIP Belt for MediByte, Large FDA UDI
- Generic Name
- Pneumograph FDA UDI
- Device Name
- Respiratory Effort Sensors EUDAMEDBelt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. FDA UDI
- Model / Reference
- 8574 EUDAMEDFDA UDI
- Description
- Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte. FDA UDI
Identifiers
- Catalog Number
- 8574 FDA UDI
- Primary DI / UDI-DI
- B14085740 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140EffortFU EUDAMED
- Direct Marketing DI
- B14085740 EUDAMED
- 510(k) Number
- K001743 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Pneumograph 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 74 Inch FDA UDI
Rip Belt For Medibyte, Large 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 0ebfbd85-447d-4cc8-ab45-c3a9a7afe425 61 fields · synced Jul 9, 2026
- FDA UDI e52a6be2-baed-4a56-bc58-50bf98262a8e 38 fields · synced May 30, 2026