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MiroCam Capsule Endoscope System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MC2S2TYYMMDDNNNModel MC2000-B
Identity
- Trade Name
- MiroCam Capusle Endoscope System FDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- MiroCam Capsule Endoscope System EUDAMED
- Model / Reference
- MC2000-B EUDAMEDFDA UDIMC2S2TYYMMDDNNN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260351 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260260351 EUDAMED
- 510(k) Number
- K170438 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-08809260260351 | 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 85aad995-1b14-4ff1-874b-095b6cedafaa 61 fields · synced Jun 6, 2026
- FDA UDI 3946c1d4-edda-409c-a404-7f1b5cf28b59 33 fields · synced May 30, 2026