Identity
- Trade Name
- Applicator Twist EUDAMED
- Device Name
- Applicator Twist EUDAMED
- Model / Reference
- DI-03-326 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004872235 EUDAMED
- Basic UDI-DI
- 8964004872235DI03326L7 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Dental appliance fabrication material, ceramic
Applicator Twist by Zasber International — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8964004872235DI03326L7 | Class I | Active |
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Manufacturer
- Manufacturer
- Zasber International
- EUDAMED SRN
- PK-MF-000046743
- Authorised Representative
- Yousfis S.L. ES-AR-000041900
Sources (1)
- EUDAMED ad5e1c82-5efe-49f7-accd-324543805125 61 fields · synced Sep 17, 2026