Identity
- Trade Name
- Fog Free De Mist Solution EUDAMED
- Device Name
- Fog Free Solution EUDAMED
- Model / Reference
- TF-1022 EUDAMEDAF-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849771038047 EUDAMED
- Basic UDI-DI
- B-00849771038047 EUDAMED
- EMDN Code
- K0180 ENDOTHERAPY DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Fog Free De Mist Solution by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…
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-00849771038047 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b3c84cc8-c5c2-4254-b61e-c6e84bf93389 61 fields · synced Oct 7, 2026