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Bulkflex Acetal 22 Grande A3, 5 – Bf19
EUDAMEDClass I (EU MDR)
Ref BULKFLEX ACETAL 22 GRANDE A3,5 – BF19Model ACETAL
by Nuxen Srl
Identity
- Trade Name
- BULKFLEX ACETAL 22 GRANDE A3,5 – BF19 EUDAMED
- Device Name
- BULKFLEX ACETAL EUDAMED
- Model / Reference
- ACETAL EUDAMEDBULKFLEX ACETAL 22 GRANDE A3,5 – BF19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798148622743 EUDAMED
- Basic UDI-DI
- 779814862BUACSK EUDAMED
- Direct Marketing DI
- 07798148622743 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Bulkflex Acetal 22 Grande A3, 5 – Bf19 by Nuxen Srl — Class I — 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 | 779814862BUACSK | Class I | Active |
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Manufacturer
- Manufacturer
- Nuxen Srl
- EUDAMED SRN
- AR-MF-000029448
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED f40d3af8-c508-42b4-a133-546062b4f442 61 fields · synced Jun 18, 2026
- EUDAMED f40d3af8-c508-42b4-a133-546062b4f442-1 61 fields · synced Jun 10, 2026