MiroCam Capsule Endoscope System MC2000
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Device Name
- MiroCam Capsule Endoscope System EUDAMED
- Model / Reference
- MC2000 EUDAMEDMC2S1TYYMMDDNNN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260344 EUDAMED
- Basic UDI-DI
- B-08809260260344 EUDAMED
- EMDN Code
- Z12021201 ENDOSCOPIC CAPSULES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The MiroCam Capsule Endoscope System MC2000 is a wireless imaging device designed for gastrointestinal examination. It captures images of the digestive tract as it travels naturally through the body, providing a non-invasive alternative to traditional endoscopy.
This single-use, non-sterile device is classified as Class IIa and is not implantable, reusable, or MRI-safe. It is supplied by IntroMedic Co., Ltd. and is intended for use in clinical settings under professional supervision. The system includes the capsule and associated recording equipment for data capture and review.
Frequently asked questions
Is the MiroCam Capsule Endoscope reusable?
No, the device is marked as single-use (REUSABLE: 0). It is designed for one patient only to ensure safety and hygiene.
Does the MiroCam system require sterilization before use?
No, the specifications list STERILE: 0 and STERILIZATION: 0, indicating it is supplied non-sterile and does not require sterilization prior to administration.
Is the MiroCam capsule implantable?
No, the IMPLANTABLE field is set to 0. The capsule is ingested and passes through the digestive tract naturally; it is not surgically placed or retained in the body.
What is the device classification of the MiroCam system?
It is classified as Class IIa under medical device regulations, indicating a moderate risk level requiring regulatory oversight and conformity assessment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: JUN 3 02014 - accessdata.fda.gov, About - IntroMedic America, IntroMedic Co., Ltd., Product | IntroMedic - 인트로메딕, A New Active Locomotion Capsule Endoscopy under Magnetic ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252617 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K170438 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K134005 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K140751 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K180732 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K111450 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K143663 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K123428 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809260260344 | Class IIa | Active |
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Manufacturer
- Manufacturer
- IntroMedic Co., Ltd.
- EUDAMED SRN
- KR-MF-000024897
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 48a12a05-467c-486e-9a54-a30837e2f12a 85 fields · synced Sep 18, 2026
- FDA 510(k) K252617 1 fields · synced May 21, 2026