Identity
- Trade Name
- RETRACTOR EUDAMED
- Device Name
- RETRACTOR EUDAMED
- Model / Reference
- 1008-19A EUDAMED1008-13A EUDAMED989 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D123100819A0 EUDAMEDD123100813A0 EUDAMEDD1239890 EUDAMED
- Basic UDI-DI
- B-D123100819A0 EUDAMED++D123100813AH3 EUDAMED++D123989JR EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Retractor by Dental Expert — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | B-D123100819A0 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-D123100819A0 | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (3)
- EUDAMED ec51f536-089f-45e4-ae31-6e443c4bf1ab 61 fields · synced Jul 26, 2026
- EUDAMED 9f10daeb-651a-426a-bb2a-c3c0e85321bd 61 fields · synced May 17, 2026
- EUDAMED f96bf52c-e80a-45b7-ad05-7ce0110680c6 61 fields · synced May 19, 2026