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MiroCam Capsule Endoscope System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MC1G2TYYMMDDNNNModel MC1200-B
Identity
- Trade Name
- MiroCam Capsule Endoscope System FDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- MiroCam Capsule Endoscope System EUDAMED
- Model / Reference
- MC1200-B EUDAMEDFDA UDIMC1G2TYYMMDDNNN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260566 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260260566 EUDAMED
- 510(k) Number
- K143663 FDA UDI
- FDA Product Code
- NEZ FDA UDI
- EMDN Code
- Z12021201 ENDOSCOPIC CAPSULES EUDAMED
- GMDN Term
- Video capsule endoscopy system capsule FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MiroCam Capsule Endoscope System by IntroMedic Co., LTD. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260260566 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 b20a7f35-ebbd-447d-8b9e-50213805430f 61 fields · synced May 31, 2026
- FDA UDI 15c0acf7-443e-4bba-a029-38bb5420c012 33 fields · synced May 29, 2026