Identity
- Trade Name
- NOCISCAN Suite EUDAMEDNociCalc FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- NOCISCAN Suite EUDAMEDMRS calculator FDA UDI
- Model / Reference
- 200-00201 EUDAMEDNocicalc FDA UDI
- Description
- MRS calculator FDA UDI
Identifiers
- Catalog Number
- 200-00301 FDA UDI
- Primary DI / UDI-DI
- 00860010437209 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860010437209 EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NOCISCAN Suite by Aclarion Inc — Class I — 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-00860010437209 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aclarion Inc
- EUDAMED SRN
- US-MF-000042192
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 88bdcd3b-b588-4693-962a-1337274f530e 61 fields · synced Jun 19, 2026
- FDA UDI d6914253-1948-4275-af28-e1b7811786f0 35 fields · synced May 29, 2026