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Bulkflex Acetal 22 Grande B3 – Bf20
EUDAMEDClass I (EU MDR)
Ref BULKFLEX ACETAL 22 GRANDE B3 – BF20Model ACETAL
by Nuxen Srl
Identity
- Trade Name
- BULKFLEX ACETAL 22 GRANDE B3 – BF20 EUDAMED
- Device Name
- BULKFLEX ACETAL EUDAMED
- Model / Reference
- ACETAL EUDAMEDBULKFLEX ACETAL 22 GRANDE B3 – BF20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798148622750 EUDAMED
- Basic UDI-DI
- 779814862BUACSK EUDAMED
- Direct Marketing DI
- 07798148622750 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 B3 – Bf20 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 (1)
- EUDAMED b28d4dfb-83e4-4010-badf-46be0904c81b 61 fields · synced Jul 23, 2026