Identity
- Device Name
- Cuff Pressure Tube EUDAMED
- Model / Reference
- 282016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512926665 EUDAMED
- Basic UDI-DI
- 037005129ACC01MQ EUDAMED
- EMDN Code
- R01038001 ENDOTRACHEAL TUBE CUFFS INFLATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Cuff Pressure Tube 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 | 037005129ACC01MQ | 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 94b72428-9db0-424f-9ff0-4b2f1cc77619 61 fields · synced Jun 19, 2026