Identity
- Trade Name
- Serenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- PZ01 Piezo Sensor EUDAMEDSerenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m FDA UDI
- Model / Reference
- PZ01 EUDAMEDFDA UDIS60780 EUDAMED
- Description
- Serenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m FDA UDI
Identifiers
- Catalog Number
- S60780 FDA UDI
- Primary DI / UDI-DI
- 00817111020960 EUDAMEDFDA UDI
- Basic UDI-DI
- 081711102PIEZO2M EUDAMED
- Direct Marketing DI
- 00817111020960 EUDAMED
- 510(k) Number
- K181709 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
PZ01 Piezo 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 | 081711102PIEZO2M | 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 42dc8b00-97e2-4aae-bbdd-dee55b3aabef 61 fields · synced Jun 17, 2026
- FDA UDI 3653cffe-1e21-4992-8912-7100e59e9ace 35 fields · synced May 30, 2026