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PUREbulk Fill Flow, Syringe, 2.3g
EUDAMEDClass IIa (EU MDR)
Ref 721305Model PUREbulk fill flow
by Dent4You AG
Identity
- Trade Name
- PUREbulk Fill Flow, Syringe, 2.3g EUDAMED
- Model / Reference
- PUREbulk fill flow EUDAMED721305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630243692064 EUDAMED
- Basic UDI-DI
- 76303929COMP200410EY EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Dental composite resin
PUREbulk Fill Flow, Syringe, 2.3g by Dent4You AG — Class IIa — 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 | 76303929COMP200410EY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Dent4you GmbH DE-AR-000006093
Sources (1)
- EUDAMED 3123c430-c0dd-485b-b411-339ad7c3b72e 61 fields · synced Jun 18, 2026