Identity
- Trade Name
- Silicone Mask EUDAMED
- Device Name
- Silicone Mask EUDAMED
- Model / Reference
- 1611-9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961931355 EUDAMED
- Basic UDI-DI
- B-04710961931355 EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Silicone Mask by Fortune Medical Instrument Corp. — 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-04710961931355 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1c8cbc65-b2b9-49aa-9d21-4326419509c1 61 fields · synced Jul 27, 2026