Identity
- Trade Name
- Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- TH01 Thermocouple Sensor EUDAMEDSerenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m FDA UDI
- Model / Reference
- TH01 EUDAMEDFDA UDIS53260 EUDAMED
- Description
- Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m FDA UDI
Identifiers
- Catalog Number
- S53260 FDA UDI
- Primary DI / UDI-DI
- 00817111021066 EUDAMEDFDA UDI
- Basic UDI-DI
- 081711102THERM2W EUDAMED
- Direct Marketing DI
- 00817111021066 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
TH01 Thermocouple 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 | 081711102THERM2W | 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 c29c499f-2a1f-4252-846e-6db39eed0025 61 fields · synced Jun 19, 2026
- FDA UDI 626bb6ec-10d0-4907-b455-f2eda38e8d70 35 fields · synced May 30, 2026