Identity
- Trade Name
- IRRIS2 EUDAMEDIRRIS FDA UDI
- Generic Name
- Intubation light source FDA UDI
- Device Name
- IRRIS2 EUDAMEDThe IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes) FDA UDI
- Model / Reference
- IRRIS2 EUDAMED1210001A1 EUDAMED025-04 FDA UDI
- Description
- The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290121380010 EUDAMED00608614324521 FDA UDI
- Basic UDI-DI
- 729012138IRRIS2D9 EUDAMED
- 510(k) Number
- K171411 FDA UDI
- FDA Product Code
- BTR FDA UDI
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Intubation light source FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Market of Registration
- Denmark 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intubation light source
Irris by A.R Guide IN Medical , Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intubation light source.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Clarus TURBO LED Light Source — CLARUS MEDICAL, LLC · Class II
- BritePro Single-Use Fiber Optic Lightsource — FLEXICARE MEDICAL LIMITED · Class I
- IRRIS — A.R Guide IN Medical , Ltd. · Class II
Cleared under the same submission
K171411 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A.R Guide IN Medical , Ltd.
Sources (2)
- FDA UDI 9e4c52da-93d4-4fcd-a010-e13992f49cfe 34 fields · synced Sep 17, 2026
- EUDAMED d80cf371-a54e-4feb-b0fa-1a3bffe4a395 61 fields · synced Sep 17, 2026