Identity
- Device Name
- Class I - Dental Instruments EUDAMED
- Model / Reference
- D2OCal-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290111273148 EUDAMED
- Basic UDI-DI
- 729011127TOOLSClassI3T EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Class I - Dental Instruments by A.B. Dental Devices Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 729011127TOOLSClassI3T | Class I | Active |
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Manufacturer
- Manufacturer
- A.B. Dental Devices Ltd
- EUDAMED SRN
- IL-MF-000008766
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 2a8af98b-93ed-4629-8465-022e92d3338a 61 fields · synced Jul 25, 2026