Identity
- Trade Name
- SLA (577 nm) EUDAMEDAssy, Top Zeiss 130 SLA FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Slit Lamp Adapter (SLA) EUDAMED
- Model / Reference
- 65623 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813125017095 EUDAMED00813125014681 FDA UDI
- Basic UDI-DI
- 081312501SLA9W EUDAMED
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12120108 SLIT LAMPS EUDAMED
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class I 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
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
Yes
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
SLA (577 nm) by Iridex Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081312501SLA9W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Iridex Corporation
- EUDAMED SRN
- US-MF-000029814
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ce7babd2-8167-4a70-9458-df15e088b878 61 fields · synced Jul 22, 2026
- FDA UDI 0bfbf9fe-ce76-4547-9e23-d15fcd921cdf 32 fields · synced May 30, 2026