Identity
- Trade Name
- Impression Coping EUDAMED
- Device Name
- Impression Coping EUDAMED
- Model / Reference
- ICTH5515R15T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800055788401 EUDAMED
- Basic UDI-DI
- 88000557IMPCQ4 EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Category: Dental implant suprastructure, temporary, preformed, single-use
Introducing the Impression Coping, a revolutionary medical device designed to provide accurate and efficient impression taking for dental procedures. With its advanced technology and user-friendly interface, this device ensures high-quality impressions that meet the highest standards of patient care.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000557IMPCQ4 | Class I | Active |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
- EUDAMED SRN
- KR-MF-000009313
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED 9889d5d7-b3a4-4083-990b-ed526b81cf7f 61 fields · synced Jul 16, 2026