← Back to catalogue

MiroCam Capsule Endoscope System

FDA UDIEUDAMED

Class II (US FDA UDI)

by IntroMedic Co., LTD.

Identity

Trade Name
MiroCam Capsule Endoscope System FDA UDI
Generic Name
Video capsule endoscopy system FDA UDI
Model / Reference
MR1000-S FDA UDI

Identifiers

Primary DI / UDI-DI
08809260260429 FDA UDI
510(k) Number
K140751 FDA UDI
K143663 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Video capsule endoscopy system

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

Similar devices

Also classified as Video capsule endoscopy system.

Cleared under the same submission

K140751 also covers:

K143663 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
IntroMedic Co., LTD.

Sources (2)

  • FDA UDI e1ca04e7-f18d-4a80-9626-388028ddbb3a 33 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026