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MiroCam Capusle Endoscope System

FDA UDI

Class II (US FDA UDI)

by IntroMedic Co., LTD.

Identity

Trade Name
MiroCam Capusle Endoscope System FDA UDI
Generic Name
Video capsule endoscopy system capsule FDA UDI
Device Name
Package System(MC2000-B Capsule and MR2000 Receiver) FDA UDI
Model / Reference
MC2000-B, MR2000 FDA UDI
Description
Package System(MC2000-B Capsule and MR2000 Receiver) FDA UDI

Identifiers

Primary DI / UDI-DI
08809260260436 FDA UDI
510(k) Number
K170438 FDA UDI
FDA Product Code
NEZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Video capsule endoscopy system capsule

MiroCam Capusle 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 capsule.

Cleared under the same submission

K170438 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IntroMedic Co., LTD.

Sources (1)

  • FDA UDI ac4d7170-c824-4adf-8249-92bcb26fb3f2 34 fields · synced Jun 1, 2026