Identity
- Trade Name
- MiroCam Capsule Endoscope System FDA UDI
- Generic Name
- Video capsule endoscopy system FDA UDI
- Model / Reference
- MR1100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260260184 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Video capsule endoscopy system
MiroCam Capsule Endoscope System by IntroMedic Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — 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:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IntroMedic Co., LTD.
Sources (1)
- FDA UDI aa3f7c87-5cd6-44cb-b618-55a42d82e453 33 fields · synced May 30, 2026