Identity
- Trade Name
- Clarus Dual HDMI Enclosure EUDAMEDFDA UDI
- Generic Name
- Instrument inspection scope FDA UDI
- Device Name
- Clarus Dual HDMI Enclosure EUDAMEDThe Clarus Dual HDMI Enclosure is a device used with a with a Clarus Digital Inspection Scope and is intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The Clarus Dual HDMI Enclosure provides a white light source and facilitates the image from the camera sensor to a monitor. This is a reusable device. FDA UDI
- Model / Reference
- CD-HDMI EUDAMEDFDA UDI
- Description
- The Clarus Dual HDMI Enclosure is a device used with a with a Clarus Digital Inspection Scope and is intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The Clarus Dual HDMI Enclosure provides a white light source and facilitates the image from the camera sensor to a monitor. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- CD-HDMI FDA UDI
- Primary DI / UDI-DI
- 10810004820804 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000482CD24J EUDAMED
- Direct Marketing DI
- 00810004820807 EUDAMED
- FDA Product Code
- MNL FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Instrument inspection scope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Clarus Dual HDMI Enclosure by Clarus Medical, Llc — 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 | 081000482CD24J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clarus Medical, LLC
- EUDAMED SRN
- US-MF-000025783
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 63da4a94-5218-49ca-88db-c5b34d629619 61 fields · synced Sep 18, 2026
- FDA UDI 21787031-41e2-4ee5-a833-df28cc0fbb6f 34 fields · synced May 30, 2026