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MiroCam Capsule Endoscope System
EUDAMEDClass IIa (EU MDR)
Ref MC2S1TYYMMDDNNNModel MC2000
Identity
- Device Name
- MiroCam Capsule Endoscope System EUDAMED
- Model / Reference
- MC2000 EUDAMEDMC2S1TYYMMDDNNN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260610 EUDAMED
- Basic UDI-DI
- B-08809260260610 EUDAMED
- EMDN Code
- Z12021201 ENDOSCOPIC CAPSULES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
MiroCam Capsule Endoscope System by IntroMedic Co., LTD. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260260610 | Class IIa | Active |
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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 (1)
- EUDAMED 8f196e20-581b-4657-a634-a7c686bf5ba8 61 fields · synced May 22, 2026