Infrascanner 2000
Ref 2000
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08616060003INFRAN2 00861606000302 | Date17 Jul 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00861606000302 | Date22 Dec 2017 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Infrascanner
- Generic Name
- Near-infrared intracranial haematoma detector
- Model / Ref / Catalog
- 2000
- Primary DI / UDI-DI
- 00861606000302
- Basic UDI-DI
- 08616060003INFRAN2
- Direct Marketing DI
- 00861606000302
- 510(k) Number
- FDA Product Code
- OPT
- EMDN Code
- Z12109006 Brain tissue monitoring systems
- GMDN Term
- Near-infrared intracranial haematoma detector
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 882.1935
- EU market of registration
- Türkiye
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Infrascan, Inc.
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No