Identity
- Device Name
- Dual Rinse HEDP 10 EUDAMED
- Model / Reference
- 10000042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649992165019 EUDAMED
- Basic UDI-DI
- B-07649992165019 EUDAMED
- EMDN Code
- Q01010399 DENTAL MEDICATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Dual Rinse HEDP 10 by Medcem GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-07649992165019 | Class I | Active |
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Manufacturer
- Manufacturer
- Medcem GmbH
- EUDAMED SRN
- CH-MF-000043209
- Authorised Representative
- Medcem GmbH AT-AR-000004585
Sources (1)
- EUDAMED babcbac5-b74e-46ae-925b-f40165632dd3 61 fields · synced Jun 19, 2026