Identity
- Trade Name
- Integre Pro Scan Red-Yellow EUDAMEDFDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- Integre Pro Scan Red-Yellow EUDAMED
- Model / Reference
- LP6RY EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000151 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09342395000151 EUDAMED
- 510(k) Number
- K142398 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER EUDAMED
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- France 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
Integre Pro Scan Red-Yellow by Ellex Medical Pty 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-09342395000151 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000004802
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 9ba3a90c-422e-4bde-b46a-2908ee10d1af 61 fields · synced Jul 20, 2026
- FDA UDI 770a487d-6efc-44b0-afdb-5d81a0bb3ea5 33 fields · synced May 30, 2026