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DTX Studio Clinic 3.2 for Win 64-bit
EUDAMEDClass IIb (EU MDR)
Ref 300851_V3.2_WIN64
Identity
- Trade Name
- DTX Studio Clinic 3.2 for Win 64-bit EUDAMED
- Device Name
- Diagnostic and treatment software EUDAMED
- Model / Reference
- 300851_V3.2_WIN64 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07332747199512 EUDAMED
- Basic UDI-DI
- 73327470000002206S EUDAMED
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DTX Studio Clinic 3.2 for Win 64-bit by Nobel Biocare AB — Class IIb — 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 | 73327470000002206S | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (1)
- EUDAMED 9a76c7db-50f0-484f-a41f-f5a724e3f22d 61 fields · synced Jul 18, 2026