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Ultima Body Position Sensor with 2.5 mm Phone Connector
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 0534Model 0532
Identity
- Trade Name
- Ultima Body Position Sensor with 2.5 mm Phone Connector EUDAMED
- Device Name
- Ultima Body Position Sensor EUDAMED
- Model / Reference
- 0532 EUDAMED0534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B1400534TY EUDAMED
- Basic UDI-DI
- ++B140BodyPositionVB EUDAMED
- Direct Marketing DI
- B14005340 EUDAMED
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Ultima Body Position Sensor with 2.5 mm Phone Connector by Braebon Medical Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981969 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++B140BodyPositionVB | Class I | Active |
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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 1fb06b83-fbbf-4c8b-a7b6-3b5a6f67954f 61 fields · synced Oct 6, 2026
- FDA 510(k) K981969 1 fields · synced May 18, 2026