Identity
- Trade Name
- PROBE COVER MC-EP2 (MC-EP2-E) EUDAMED
- Device Name
- PROBE COVER MC-EP2 EUDAMED
- Model / Reference
- MC-EP2-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672107885 EUDAMED
- Basic UDI-DI
- 40156721078869 EUDAMED
- EMDN Code
- V030180 BODY TEMPERATURE MEASURING DEVICES - 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
Probe Cover Mc-Ep2 (mc-Ep2-E) by OMRON Healthcare 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 | 40156721078869 | Class I | Active |
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Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED abe16f3a-cc05-43a3-b447-64705c5147e0 61 fields · synced Jun 19, 2026