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Smoke Filter
EUDAMEDClass I (EU MDR)
Ref SAF1 N120Model TUBO SPIRALATO CM. 200Ref SFA1 N120
by Biogyn Srl
Identity
- Trade Name
- SMOKE FILTER EUDAMED
- Device Name
- TUBO SPIRALATO EUDAMED
- Model / Reference
- TUBO SPIRALATO CM. 200 EUDAMEDSAF1 N120 EUDAMEDSFA1 N120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18056977352030 EUDAMED18056977352047 EUDAMED
- Basic UDI-DI
- 805697735003JN EUDAMED
- Direct Marketing DI
- 18056977352030 EUDAMED18056977352047 EUDAMED
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Smoke Filter by Biogyn Srl — 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 | 805697735003JN | Class I | Active |
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Manufacturer
- Manufacturer
- Biogyn Srl
- EUDAMED SRN
- IT-MF-000033403
Sources (2)
- EUDAMED 02fc7b67-add0-4c6a-bcd9-c6bac94b9087 61 fields · synced Jul 28, 2026
- EUDAMED 1ef6c0be-a281-41f2-b268-5e4e1f3e96ce 61 fields · synced May 18, 2026