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Enigma High Base
EUDAMEDClass IIa (EU MDR)
Ref 0846-PVModel Enigma High Base Std Pk PV
Identity
- Trade Name
- Enigma High Base EUDAMEDEnigma High Base Std Pk PV EUDAMED
- Device Name
- 0846-PV EUDAMED
- Model / Reference
- Enigma High Base Std Pk PV EUDAMED0846-PV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052674088261 EUDAMED
- Basic UDI-DI
- B-05052674088261 EUDAMED
- EMDN Code
- Q010305 SURGICAL DENTISTRY CEMENTS EUDAMED
Classification
- Device Class
- Class IIa 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
Enigma High Base by Davis Schottlander & Davis Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05052674088261 | Class IIa | 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 d9fd538d-3220-4e41-963e-9114ce1175ed 61 fields · synced Jun 18, 2026
- EUDAMED f74a18e0-4226-403a-89f9-a15574e98916 61 fields · synced Jun 18, 2026