MiroCam Capsule Endoscope System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref BELT-M0001-YYMMDD

by IntroMedic Co., LTD.

Identity

Trade Name: MiroCam Capsule Endoscope System FDA UDI
Generic Name: Video capsule endoscopy system FDA UDI
Device Name: MiroCam Data Belt EUDAMED
Model / Reference: BELT-M0001-YYMMDD EUDAMED
MR1000-D(M) FDA UDI

Identifiers

Primary DI / UDI-DI: 08809260260405 EUDAMEDFDA UDI
Basic UDI-DI: 880926026007GM EUDAMED
510(k) Number: K140751 FDA UDI
K143663 FDA UDI
FDA Product Code: NEZ FDA UDI
EMDN Code: Z12021280 ENDOSCOPIC CAPSULE SIGNAL RECEIVERS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Video capsule endoscopy system FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 876.1300 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Video capsule endoscopy system

MiroCam Capsule Endoscope System by IntroMedic Co., LTD. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system.

MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II

Cleared under the same submission

K140751 also covers:

K143663 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: IntroMedic Co., LTD.

Sources (2)

FDA UDI e07d8b01-ae3a-46cd-9b67-14bd021fb960 33 fields · synced Jun 19, 2026
EUDAMED 6f7173ff-15d2-47cb-9905-6e42891b4532 61 fields · synced Jun 19, 2026