Identity
- Trade Name
- BIOXEL EUDAMEDFDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Fractional CO2 Laser EUDAMED
- Model / Reference
- BIOXEL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800042100018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800042100018 EUDAMED
- 510(k) Number
- K173359 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Bioxel by Ami Inc. — Class IIb — 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-08800042100018 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ami Inc.
- EUDAMED SRN
- KR-MF-000017522
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 234e4dbb-a13d-41a9-842d-bace0e6f2a52 61 fields · synced Jun 18, 2026
- FDA UDI 79a8fcb5-5ed7-4a75-b4a4-bcfaedd8f902 34 fields · synced May 30, 2026