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enigmalife Digital
EUDAMEDClass IIa (EU MDR)
Ref ELDA:BL3:ITD5Model enigmalife Digital Anterior Denture Teeth
Identity
- Trade Name
- enigmalife Digital EUDAMED
- Device Name
- ELDA:BL3:ITD5 EUDAMED
- Model / Reference
- enigmalife Digital Anterior Denture Teeth EUDAMEDELDA:BL3:ITD5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052674122347 EUDAMED
- Basic UDI-DI
- B-05052674122347 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-05052674122347 | 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 ebc13798-fd46-471e-a657-6de84a376757 61 fields · synced Jun 18, 2026