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Bulkflex Acetal 25 Grande A3, 5 – Bf31
EUDAMEDClass I (EU MDR)
Ref BULKFLEX ACETAL 25 GRANDE A3,5 – BF31Model ACETAL
by Nuxen Srl
Identity
- Trade Name
- BULKFLEX ACETAL 25 GRANDE A3,5 – BF31 EUDAMED
- Device Name
- BULKFLEX ACETAL EUDAMED
- Model / Reference
- ACETAL EUDAMEDBULKFLEX ACETAL 25 GRANDE A3,5 – BF31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798148622897 EUDAMED
- Basic UDI-DI
- 779814862BUACSK EUDAMED
- Direct Marketing DI
- 07798148622897 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 25 Grande A3, 5 – Bf31 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 e4dbb01d-7923-4261-91cc-73cf38094987 61 fields · synced Jun 20, 2026
- EUDAMED e4dbb01d-7923-4261-91cc-73cf38094987-1 61 fields · synced Jun 10, 2026