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Fidelity
EUDAMEDClass I (EU MDR)
Ref 857Model Fidelity 25 Economy Pack (Pk 4)Model Alginate Impression Materials
Identity
- Trade Name
- Fidelity EUDAMEDFidelity 25 Economy Pack (Pk 4) EUDAMED
- Device Name
- 857 EUDAMEDAlginate Mat. EUDAMED
- Model / Reference
- Fidelity 25 Economy Pack (Pk 4) EUDAMED857 EUDAMEDAlginate Impression Materials EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052674088346 EUDAMED
- Basic UDI-DI
- B-05052674088346 EUDAMED5052674ALG-IMP-MATR4 EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Fidelity by Davis Schottlander & Davis Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05052674088346 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05052674088346 | Class I | Active |
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Manufacturer
- Manufacturer
- Davis Schottlander & Davis Ltd
- EUDAMED SRN
- GB-MF-000035008
- Authorised Representative
- Schottlander (IRL) Ltd IE-AR-000029625
Sources (2)
- EUDAMED 7ae7a193-e1f1-4477-9ee7-39064da5bd18 61 fields · synced Jul 23, 2026
- EUDAMED a8f1daf5-dadb-4c17-94d9-0a5acd86cb45 61 fields · synced Jul 23, 2026