Identity
- Trade Name
- EASI-C EUDAMED
- Device Name
- EASI-C EUDAMEDAnti-Fog Solution EUDAMED
- Model / Reference
- FC00013-100AD EUDAMEDAAF-IBB10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654200688 EUDAMED
- Basic UDI-DI
- B-05060654200688 EUDAMED471160599AAF012B EUDAMED
- EMDN Code
- K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Easi-C by Advanced Medical Design Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05060654200688 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05060654200688 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Medical Design Co., Ltd.
- EUDAMED SRN
- TW-MF-000019772
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 496ec4f7-84cc-4246-979e-4cb14c2a1649 61 fields · synced Jul 8, 2026
- EUDAMED b0f1dcdb-abda-455a-8946-d1c6595570d6 61 fields · synced May 18, 2026