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enigmalife Digital
EUDAMEDClass IIa (EU MDR)
Ref ELDP:B3:P1DUModel enigmalife Digital Posterior Denture Teeth
Identity
- Trade Name
- enigmalife Digital EUDAMED
- Device Name
- ELDP:B3:P1DU EUDAMED
- Model / Reference
- enigmalife Digital Posterior Denture Teeth EUDAMEDELDP:B3:P1DU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052674128011 EUDAMED
- Basic UDI-DI
- B-05052674128011 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES 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
enigmalife Digital 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-05052674128011 | 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 (1)
- EUDAMED 376b2bb4-5c93-4e24-96a4-bf1810d612c4 61 fields · synced Jun 19, 2026