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Mirror Handle
EUDAMEDClass I (EU MDR)
Ref 1011-4BRef 1011-4ARef 1011-4Ref 1011-3
Identity
- Trade Name
- MIRROR HANDLE EUDAMED
- Device Name
- MIRROR HANDLE EUDAMED
- Model / Reference
- 1011-4B EUDAMED1011-4A EUDAMED1011-4 EUDAMED1011-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D12310114B0 EUDAMEDD12310114A0 EUDAMEDD123101140 EUDAMEDD123101130 EUDAMED
- Basic UDI-DI
- ++D12310114BWK EUDAMED++D12310114AWH EUDAMED++D12310114B8 EUDAMED++D12310113B6 EUDAMED
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMEDL160201 DENTAL MIRRORS AND HANDLES, 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
Mirror Handle by Dental Expert — 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 | ++D12310114BWK | 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 (4)
- EUDAMED dc416d7d-68d7-470d-a1b9-c196930108d2 61 fields · synced Aug 4, 2026
- EUDAMED 13ff34b8-04e5-438d-9d68-64867cc37df8 61 fields · synced May 18, 2026
- EUDAMED 93e76a57-0ca6-4098-b403-78a2f811a5b6 61 fields · synced May 18, 2026
- EUDAMED 9dcb112a-5ae5-45ff-8223-809b8288c05b 61 fields · synced May 18, 2026