Identity
- Trade Name
- SLA (532 nm) EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Slit Lamp Adapter (SLA) EUDAMEDfor Zeiss 30 CSO or equivalent FDA UDI
- Model / Reference
- 65505 EUDAMEDFDA UDI66273 EUDAMED65506 EUDAMED
- Description
- for Zeiss 30 CSO or equivalent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813125017019 EUDAMEDFDA UDI00813125016531 EUDAMED00813125014698 EUDAMED
- Basic UDI-DI
- 081312501SLA9W EUDAMED
- FDA Product Code
- GEX 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
- 878.4810 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 (532 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 (4)
- EUDAMED 81cbcbc4-959d-4c85-bf32-26047681c27f 61 fields · synced Jul 23, 2026
- EUDAMED 58b4221f-3ea1-485e-be71-9afb5deae9a1 61 fields · synced May 18, 2026
- EUDAMED ca6b54f6-4015-4cd0-9588-6663d322f7dc 61 fields · synced May 18, 2026
- FDA UDI 0bd41a6e-21a0-425f-ba2a-386ee81a2dfa 34 fields · synced May 30, 2026