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SLA 50 µm (532 nm)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 31172-01

by Iridex Corporation

Identity

Trade Name
SLA 50 µm (532 nm) EUDAMED
SLA 532nm 50 um Haag Streit 900 BM w/MM FDA UDI
Generic Name
General/multiple surgical diode laser system FDA UDI
Device Name
Slit Lamp Adapter (SLA) EUDAMED
Model / Reference
31172-01 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00813125011178 EUDAMEDFDA 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 EUDAMED
Class 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 50 µm (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

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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 631c8032-af3f-4946-a4fe-c0ba380be4d2 61 fields · synced Aug 3, 2026
  • FDA UDI 8b474bb3-a8ec-4376-8882-c53e4e5fd576 33 fields · synced May 30, 2026