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Smartrion Combi
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IDS-UM-0631Model SMARTRION COMBI
by Ids Ltd.
Identity
- Trade Name
- SMARTRION COMBI EUDAMEDAlexandrite & Long Pulsed Nd:YAG Laser FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- Alexandrite&Long Pulsed Nd:YAG Laser EUDAMED
- Model / Reference
- SMARTRION COMBI EUDAMEDFDA UDIIDS-UM-0631 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809578390344 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809578390344 EUDAMED
- 510(k) Number
- K222485 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011012 DYE/ALEXANDRITE SURGICAL LASER EUDAMED
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Spain 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
Smartrion Combi by Ids Ltd. — 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-08809578390344 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ids Ltd.
- EUDAMED SRN
- KR-MF-000018259
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 421b450d-d306-4c61-83c1-6eac199a8831 61 fields · synced May 30, 2026
- FDA UDI 96ae91b1-3d05-4470-b631-e7961d74d345 34 fields · synced May 30, 2026