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ND Digital Model Analog
EUDAMEDClass I (EU MDR)
Ref MND1000Model Dental Digital AnalogModel Dental Accessory
Identity
- Trade Name
- ND Digital Model Analog EUDAMED
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- Dental Digital Analog EUDAMEDMND1000 EUDAMEDDental Accessory EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260525165387 EUDAMEDD-DEMF000009412MND10006T EUDAMED
- Basic UDI-DI
- 426052516DigitAnalogRep8K EUDAMEDB-DEMF000009412MND10006T EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMEDQ010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Category: Dental implant suprastructure, temporary, preformed, single-use
ND Digital Model Analog by Medigma Biomedical Gmbh — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 426052516DigitAnalogRep8K | Class I | Active |
| EUDAMED | European Union | CE/MDR | 426052516DigitAnalogRep8K | Class I | Active |
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Manufacturer
- Manufacturer
- Medigma Biomedical Gmbh
- EUDAMED SRN
- DE-MF-000009412
Sources (2)
- EUDAMED f6164b35-b9bd-4eb4-938e-54a6fdf52a38 61 fields · synced Oct 6, 2026
- EUDAMED ebf670d1-c4d2-414c-909b-8b664ebcc0ec 61 fields · synced May 18, 2026