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Bulkflex Elastik 25 Grande El3 – Bf54
EUDAMEDClass I (EU MDR)
Ref BULKFLEX ELASTIK 25 GRANDE EL3 – BF54Model ELASTIK
by Nuxen Srl
Identity
- Trade Name
- BULKFLEX ELASTIK 25 GRANDE EL3 – BF54 EUDAMED
- Device Name
- BULKFLEX ELASTIK EUDAMED
- Model / Reference
- ELASTIK EUDAMEDBULKFLEX ELASTIK 25 GRANDE EL3 – BF54 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07798148623559 EUDAMED
- Basic UDI-DI
- 779814862ELASST EUDAMED
- Direct Marketing DI
- 07798148623559 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 Elastik 25 Grande El3 – Bf54 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 | 779814862ELASST | 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 bb79c25c-2812-45fc-9e7a-c6924c2295ad 61 fields · synced Jun 19, 2026