Identity
- Trade Name
- Integre Pro Red-Yellow EUDAMEDIntegre Pro Red/Yellow FDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- Integre Pro Green EUDAMEDIntegre Pro Red-Yellow EUDAMED
- Model / Reference
- LP5532 EUDAMEDL2RY EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342395000236 EUDAMEDFDA UDI
- Basic UDI-DI
- 9342395PCOG7K EUDAMEDB-09342395000236 EUDAMED
- 510(k) Number
- K081565 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
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 Red-Yellow by Ellex Medical Pty Ltd — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 9342395PCOG7K | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 9342395PCOG7K | 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 (3)
- EUDAMED 9df5acca-d12c-496d-bb26-ecfa5e1eebfd 61 fields · synced Jun 20, 2026
- EUDAMED b2f60c31-31b2-4085-abf2-1748696cdfbe 61 fields · synced May 19, 2026
- FDA UDI bedc2372-ada8-4266-b343-c10fad9e0399 33 fields · synced May 30, 2026