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Breeze- Airclean Dental Mirror
EUDAMEDClass I (EU MDR)
Ref AMYH180045Model M3Ref AMYH180065Ref AMYH180026Ref AMYH180050Ref AMYH180016Ref AMYH180068Ref AMYH180063Ref AMYH180051Ref AMYH180015Ref AMYH180048Ref AMYH180023Ref AMYH180019Ref AMYH180020Ref AMYH180066
Identity
- Device Name
- Breeze- Airclean Dental Mirror EUDAMED
- Model / Reference
- M3 EUDAMEDAMYH180045 EUDAMEDAMYH180065 EUDAMEDAMYH180026 EUDAMEDAMYH180050 EUDAMEDAMYH180016 EUDAMEDAMYH180068 EUDAMEDAMYH180063 EUDAMEDAMYH180051 EUDAMEDAMYH180015 EUDAMEDAMYH180048 EUDAMEDAMYH180023 EUDAMEDAMYH180019 EUDAMEDAMYH180020 EUDAMEDAMYH180066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879274349 EUDAMED04719879275209 EUDAMED04719879278743 EUDAMED04719879275629 EUDAMED04719879274868 EUDAMED04719879275230 EUDAMED04719879275186 EUDAMED04719879275407 EUDAMED04719879274264 EUDAMED04719879275605 EUDAMED04719879279177 EUDAMED04719879275346 EUDAMED04719879275582 EUDAMED04719879275216 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 (14)
- EUDAMED c3a28679-2c94-4708-baa4-96c5c8066ed8 61 fields · synced Aug 4, 2026
- EUDAMED 10d1b2c7-6184-42f3-9813-a579219d1027 61 fields · synced May 11, 2026
- EUDAMED 3db2b1b9-0215-4364-83ab-118d7faafe3b 61 fields · synced May 16, 2026
- EUDAMED 2279332f-2fb2-4688-8c34-2018d8ccfed4 61 fields · synced May 16, 2026
- EUDAMED dcf3d042-fa2f-4ad2-bf57-507304dd8e64 61 fields · synced May 16, 2026
- EUDAMED 01009da9-e8a9-43fc-be8a-46d6db220435 61 fields · synced May 17, 2026
- EUDAMED 27f2fcb6-35ff-4af7-9f72-dc86da78a28d 61 fields · synced May 17, 2026
- EUDAMED 55209b96-58f8-436c-99a8-5089defc118a 61 fields · synced May 17, 2026
- EUDAMED 9cb49169-f163-4ba3-b48c-b23781535949 61 fields · synced May 17, 2026
- EUDAMED 96b48b86-bebd-4fba-8ec7-abc820e9a34d 61 fields · synced May 17, 2026
- EUDAMED c41c71c6-5c18-46b8-9a35-127f6a509198 61 fields · synced May 18, 2026
- EUDAMED 36aa38a9-2af5-476f-8182-b603a7b89ee8 61 fields · synced May 18, 2026
- EUDAMED 59f28187-5f21-4a3c-8c43-97051af6fd14 61 fields · synced May 19, 2026
- EUDAMED 86e60d58-1e46-4013-802c-7259ea235e98 61 fields · synced May 19, 2026