Identity
- Trade Name
- 2RT EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- 2RT EUDAMED
- Model / Reference
- LR1532 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000212 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09342395000212 EUDAMED
- 510(k) Number
- K122202 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) 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
- 886.4390 FDA UDI
- Market of Registration
- Netherlands 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
2rt by Ellex Medical Pty 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 | K122202 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-09342395000212 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000004802
- FDA Applicant
- Ellex Medical Pty, Ltd.
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (3)
- EUDAMED d6381114-8c44-4b69-9577-cc09c19d63d7 85 fields · synced Jun 18, 2026
- FDA UDI d05fbbaa-2720-429b-8c07-45a622a922ef 34 fields · synced May 30, 2026
- FDA 510(k) K122202 1 fields · synced May 18, 2026