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MiroCam Capsule Endoscope System
EUDAMEDClass IIa (EU MDR)
Ref MC1G1TYYMMDDNNNModel MC1200Ref MC1B1TYYMMDDNNNModel MC1000Ref MC1G7TYYMMDDNNNModel MC1200-MRef MC1G6TYYMMDDNNNModel MC1200-GRef MC1Q1TYYMMDDNNNModel MC1600Ref MC1B7TYYMMDDNNNModel MC1000-WMRef MC1V1TYYMMDDNNNModel MC4000Ref MC1B5TYYMMDDNNNModel MC1000-WModel MC1000-WMRef MC2S1TYYMMDDNNNModel MC2000Model MC1000-W
Identity
- Device Name
- MiroCam Capsule Endoscope System EUDAMED
- Model / Reference
- MC1200 EUDAMEDMC1G1TYYMMDDNNN EUDAMEDMC1000 EUDAMEDMC1B1TYYMMDDNNN EUDAMEDMC1200-M EUDAMEDMC1G7TYYMMDDNNN EUDAMEDMC1200-G EUDAMEDMC1G6TYYMMDDNNN EUDAMEDMC1600 EUDAMEDMC1Q1TYYMMDDNNN EUDAMEDMC1000-WM EUDAMEDMC1B7TYYMMDDNNN EUDAMEDMC4000 EUDAMEDMC1V1TYYMMDDNNN EUDAMEDMC1000-W EUDAMEDMC1B5TYYMMDDNNN EUDAMEDMC2000 EUDAMEDMC2S1TYYMMDDNNN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260260597 EUDAMED08809260260207 EUDAMED08809260260306 EUDAMED08809260260283 EUDAMED08809260260313 EUDAMED08809260260252 EUDAMED08809260260474 EUDAMED08809260260238 EUDAMED08809260260603 EUDAMED08809260260054 EUDAMED08809260260078 EUDAMED08809260260108 EUDAMED08809260260085 EUDAMED08809260260115 EUDAMED08809260260146 EUDAMED08809260260009 EUDAMED08809260260030 EUDAMED08809260260450 EUDAMED
- Basic UDI-DI
- B-08809260260597 EUDAMEDB-08809260260207 EUDAMEDB-08809260260306 EUDAMEDB-08809260260283 EUDAMEDB-08809260260313 EUDAMEDB-08809260260252 EUDAMEDB-08809260260474 EUDAMEDB-08809260260238 EUDAMEDB-08809260260603 EUDAMEDB-08809260260054 EUDAMEDB-08809260260078 EUDAMEDB-08809260260108 EUDAMEDB-08809260260085 EUDAMEDB-08809260260115 EUDAMEDB-08809260260146 EUDAMEDB-08809260260009 EUDAMEDB-08809260260030 EUDAMEDB-08809260260450 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-08809260260597 | 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 (18)
- EUDAMED 106195fa-e1f1-4e50-81ac-661cf10f504f 61 fields · synced Oct 6, 2026
- EUDAMED 66454bd2-85ff-4d04-a0e0-7fadb20f6c22 61 fields · synced May 16, 2026
- EUDAMED b5b7ac5c-e1c1-488a-ad64-60297a742be4 61 fields · synced May 17, 2026
- EUDAMED cd3b95c1-d14c-475f-aca2-cdcf27a40097 61 fields · synced May 17, 2026
- EUDAMED 32f6ffcc-18ee-4677-8c9a-7ccae436d7c9 61 fields · synced May 17, 2026
- EUDAMED dd0ab70a-b6ee-4685-b9e5-625470b89e1b 61 fields · synced May 18, 2026
- EUDAMED 41cd645f-2acc-4ce8-b8aa-05daaddc56c6 61 fields · synced May 18, 2026
- EUDAMED d12c2897-b127-42ec-85e8-7c0234e2a1af 61 fields · synced May 18, 2026
- EUDAMED 8392aff7-58c5-4cab-be17-12c4da6234f1 61 fields · synced May 19, 2026
- EUDAMED 9313d543-baba-4c24-bc8a-221bb2b09309 61 fields · synced Jul 8, 2026
- EUDAMED f7f200a6-0198-4760-b98c-c97e8c0dba92 61 fields · synced Jul 9, 2026
- EUDAMED 7b5fa58b-f84a-4b04-85b3-776ebe7d4220 61 fields · synced Jul 12, 2026
- EUDAMED f883a0bc-38db-4d09-a6b1-983860c41e92 61 fields · synced Jul 14, 2026
- EUDAMED 64a2a3be-7da4-4187-93b5-c101bcb02365 61 fields · synced Jul 15, 2026
- EUDAMED ff9c5e57-6e7d-4366-ad9d-f5d5a25e548a 61 fields · synced Jul 15, 2026
- EUDAMED aee3f460-afe5-4411-bb9f-919fe44597e0 61 fields · synced Jul 21, 2026
- EUDAMED 83425859-e7eb-44b6-a8e6-ef62e5e3ab77 61 fields · synced Jul 27, 2026
- EUDAMED a04af249-1e21-4688-96b3-04fdf0cc1604 61 fields · synced Jul 31, 2026