Identity
- Trade Name
- Finexel EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical carbon dioxide laser system FDA UDI
- Device Name
- CO2 Surgical Laser EUDAMED
- Model / Reference
- finexel EUDAMEDFDA UDISNJ-UM-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800086000039 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800086000039 EUDAMED
- 510(k) Number
- K213557 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- General/multiple surgical carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Romania 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Finexel by Snj Co., Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, 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 | K213557 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800086000039 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SNJ Co., Ltd.
- EUDAMED SRN
- KR-MF-000026309
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 51a93c90-ede0-4c6c-a5f0-59f9360bd971 61 fields · synced Jun 19, 2026
- FDA UDI bcab82bd-1f29-4e9c-a295-029a39e3dea1 33 fields · synced May 30, 2026
- FDA 510(k) K213557 1 fields · synced May 18, 2026