enigmalife
by Davis Schottlander & Davis Ltd 1,000+ variants
Ref ELT:C1:K27CModel enigmalife Denture Teeth - Pairs
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05052674022616 05052674022616 | Date30 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number05052674022616 | Date1 Jul 2024 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- enigmalife EUDAMEDenigmalife Denture Teeth - Pairs C1:K27C GUDID
- Generic name
- Resin artificial teeth
- Device name
- ELT:C1:K27C
- Model / reference
- enigmalife Denture Teeth - Pairs, ELT:C1:K27C
- Primary DI / UDI-DI
- 05052674022616
- Basic UDI-DI
- B-05052674022616
- FDA product code
- ELM
- EMDN code
- P01020180 Dental implants - accessories
- GMDN term
- Resin artificial teeth
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 872.3590
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 0.006 Kilogram
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- GB-MF-000035008
- Authorised representative
- Schottlander (IRL) Ltd IE-AR-000029625
Other devices from Davis Schottlander & Davis Ltd
Properties
Other properties (21)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No