Identity
- Trade Name
- OccluSense® EUDAMED
- Model / Reference
- OccluSense-iPad-App EUDAMEDBK 5100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E210BK51001A EUDAMED
- Basic UDI-DI
- ++E21010x1xOSAppDA EUDAMED
- EMDN Code
- Z12119082 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
OccluSense® by Dr. Jean Bausch GmbH & Co. KG — Class I — CE/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 | ++E21010x1xOSAppDA | Class I | Active |
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Manufacturer
- Manufacturer
- Dr. Jean Bausch GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005577
Sources (1)
- EUDAMED cfcbd21d-0f08-4f35-90f0-544731e0464f 61 fields · synced Oct 7, 2026