Identity
- Device Name
- MiroCam Data Belt EUDAMED
- Model / Reference
- BELT-M0003-YYMMDD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260641 EUDAMED
- Basic UDI-DI
- 880926026007GM EUDAMED
- EMDN Code
- Z12021280 ENDOSCOPIC CAPSULE SIGNAL RECEIVERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MiroCam Data Belt by IntroMedic Co., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926026007GM | Class I | 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 0e342a70-5ae7-49f4-a661-57a0e8aff82e 61 fields · synced Jun 18, 2026