LightMat Surgical Illuminator Product Family
by Lumitex Medical Devices, Inc.
Ref 10040040
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00812432023263 00812432023263 | Date3 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00812432023263 | Date3 Sep 2026 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Thompson Surgical LitePath Integrated D 13mm
- Generic Name
- Open surgical site internal light
- Device Name
- LightMat Surgical Illuminator Product Family
- Model / Ref / Catalog
- 10040040, 013459
- Primary DI / UDI-DI
- 00812432023263
- Basic UDI-DI
- B-00812432023263
- FDA Product Code
- FDG
- EMDN Code
- V9012 Non-specialist surgical instruments and kits, single-use
- GMDN Term
- Open surgical site internal light
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 876.4530
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 10040040 | 013459 |
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000030520
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Lumitex Medical Devices, Inc.
Properties
Other properties (16)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No