Identity
- Trade Name
- LinScan 808 EUDAMED
- Device Name
- LinScan 808 EUDAMED
- Model / Reference
- 1040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B12510400M EUDAMED
- Basic UDI-DI
- B-+B12510400M EUDAMED
- 510(k) Number
- K180518 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- EMDN Code
- Z12040201 PHOTOEPILATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LinScan 808 by GME German Medical Engineering GmbH — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180518 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-+B12510400M | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GME German Medical Engineering GmbH
- EUDAMED SRN
- DE-MF-000009384
Sources (2)
- EUDAMED 22a79d78-22fd-42ff-b4b1-105d6457d78d 61 fields · synced Jul 13, 2026
- FDA 510(k) K180518 24 fields · synced May 18, 2026