Identity
- Trade Name
- Polysmith Version 12.0 FDA UDI
- Generic Name
- Sleep disorder interpretive software, professional-only FDA UDI
- Device Name
- Polysmith 12.0 EUDAMED
- Model / Reference
- 12.0 EUDAMEDFDA UDIPS12.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817111021172 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817111021172 EUDAMED
- FDA Product Code
- OLZ FDA UDIOLV FDA UDIDQA FDA UDIMNR FDA UDIGWL FDA UDIMLO FDA UDI
- EMDN Code
- Z12100592 POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Sleep disorder interpretive software, professional-only FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 FDA UDI870.2700 FDA UDI868.2375 FDA UDI882.1835 FDA UDI870.2800 FDA UDI
- Special Device Type
- -1192 EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Polysmith 12.0 by Neurotronics, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00817111021172 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6d9940d5-bc39-48f6-9cbe-f460e33c8531 61 fields · synced Jun 18, 2026
- FDA UDI aaa47c8c-d256-4828-81c0-5f335b27e84a 32 fields · synced May 30, 2026