Identity
- Trade Name
- Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- BP01 Body Position Sensor EUDAMEDSerenity BP01 Body Position Sensor, 249 Keyhole, 2.0m FDA UDI
- Model / Reference
- BP01 EUDAMEDFDA UDIS40712 EUDAMED
- Description
- Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m FDA UDI
Identifiers
- Catalog Number
- S40712 FDA UDI
- Primary DI / UDI-DI
- 00817111020847 EUDAMEDFDA UDI
- Basic UDI-DI
- 081711102BODY2V EUDAMED
- Direct Marketing DI
- 00817111020847 EUDAMED
- 510(k) Number
- K173868 FDA UDI
- FDA Product Code
- OLV FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 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
BP01 Body Position Sensor by Neurotronics, LLC — 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 | 081711102BODY2V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neurotronics, LLC
- EUDAMED SRN
- US-MF-000030839
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (2)
- EUDAMED d102c2b6-2a29-4bb9-9a17-7e3ada9ea60d 61 fields · synced Jul 10, 2026
- FDA UDI b25a893e-3ab6-4ec0-b836-297bca75ca70 35 fields · synced May 30, 2026