Identity
- Device Name
- Smoke Evacuation Lines EUDAMED
- Model / Reference
- 20323-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512925781 EUDAMED
- Basic UDI-DI
- 037005129GSU-SEYF EUDAMED
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I 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
Smoke Evacuation Lines by Promepla SAM — 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 | 037005129GSU-SEYF | Class I | Active |
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Manufacturer
- Manufacturer
- Promepla SAM
- EUDAMED SRN
- MC-MF-000015769
- Authorised Representative
- Promepla Group S.à r.l. LU-AR-000013458
Sources (1)
- EUDAMED 3f71aa41-ed31-4e9a-af79-db26e56f2068 61 fields · synced Oct 7, 2026