Organization name

CapsoVision, Inc.

SRN

US-MF-000008446

Manufacturer status

Active

10 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not re-use
• Do not use if package is damaged
• Do not use past indicated date
• MR UNSAFE
• Consult healthcare professional before use

  Prescription use only. For sale by or on the order of a physician.

• Consider hazards from magnetic fields

  Keep the magnetic wand at least 2 inches from pacemakers and other active-implant medical devices

• Type BF applied part
• Caution

  Consult accompanying documents.

• Radiation of laser apparatus

  Class 1M Laser Product. Do not view directly with optical instruments.

Primary placement in France; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00867770000261

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

086777000026SV3KITBT

Reference / catalog number

CapsoCam Plus

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

CapsoCam Plus SV-3 video capsule is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible capsule the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download, and system-control and nonvolatile flash-memory data-storage electronics. The CapsoCam Plus has four side-facing cameras arrayed around the circumference of the capsule that together image a 360º circumference and capture high-resolution color images of the mucosa. As it passes through the gastrointestinal tract under natural peristaltic movement, the capsule captures and saves images and other data in the on-board flash memory. The patient collects the capsule after it is excreted using the retrieval system, and returns it per the physician’s instruction. At the clinic that capsule is placed in a data acquisition system where the video data is downloaded from the capsule to a workstation. Custom workstation software (CVV) allows the physician to review and interpret the downloaded video images, make a diagnosis, and create a report.

Additional information URL

https://www.capsovision.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• G030701GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.