Identity
- Device Name
- Breeze- Airclean Dental Mirror EUDAMED
- Model / Reference
- M3 EUDAMEDAMYH180049 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879275384 EUDAMED
- Basic UDI-DI
- 471987927M325 EUDAMED
- EMDN Code
- L160201 DENTAL MIRRORS AND HANDLES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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
Breeze- Airclean Dental Mirror by Acme Tooling Technology Co., 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 | 471987927M325 | Class I | Active |
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Manufacturer
- Manufacturer
- Acme Tooling Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000044777
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED b46a5203-2e33-4c69-93fd-286b10d00fe2 61 fields · synced Jun 19, 2026