Identity
- Trade Name
- Ultima Body Position Sensor EUDAMEDBRAEBON Ultima Body Position Sensor FDA UDI
- Generic Name
- Patient positioning sensor FDA UDI
- Device Name
- Ultima Body Position Sensor EUDAMEDFive-position sensor to accurately record body position during sleep studies. FDA UDI
- Model / Reference
- 0532 EUDAMEDFDA UDI
- Description
- Five-position sensor to accurately record body position during sleep studies. FDA UDI
Identifiers
- Catalog Number
- 0532 FDA UDI
- Primary DI / UDI-DI
- B1400532xA0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140BodyPositionVB EUDAMED
- Direct Marketing DI
- B1400532xA0 EUDAMED
- 510(k) Number
- K981969 FDA UDI
- FDA Product Code
- LEL FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient positioning sensor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 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
Ultima Body Position Sensor 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 | ++B140BodyPositionVB | 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 73e4c7ac-d75f-4c43-9a33-8bac4416ac1a 61 fields · synced Jul 29, 2026
- FDA UDI cdf9c117-2f95-4d43-8e9d-653c077e2928 37 fields · synced May 29, 2026