Identity
- Device Name
- Dental Tubing lines EUDAMED
- Model / Reference
- 1501635-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700512926399 EUDAMED
- Basic UDI-DI
- 037005129DEN7Y EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Dental Tubing lines by Promepla SAM — Class IIa — 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 | 037005129DEN7Y | Class IIa | 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 ee46923d-7145-47f5-8fc2-8ea437ede37a 61 fields · synced Oct 6, 2026