Identity
- Trade Name
- Anti-Fog Solution EUDAMED
- Device Name
- Anti-Fog Solution EUDAMED
- Model / Reference
- AC-700 EUDAMEDAAF-IBB10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711605995085 EUDAMED
- Basic UDI-DI
- B-04711605995085 EUDAMED471160599AAF012B EUDAMED
- EMDN Code
- K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Anti-Fog Solution 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-04711605995085 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04711605995085 | 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 f163ce68-2c9c-4a57-9abc-508938c4d572 61 fields · synced May 24, 2026
- EUDAMED ee5a1176-6b24-465d-90e5-70d94e4bd1dc 61 fields · synced May 17, 2026