Identity
- Model / Reference
- Ceramic Bracket EUDAMEDC-CB-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719880833054 EUDAMED04719881570736 EUDAMED04719880833122 EUDAMED04719880833078 EUDAMED04719881570651 EUDAMED04719880833108 EUDAMED04719880833023 EUDAMED04719881570774 EUDAMED04719881570705 EUDAMED04719881570675 EUDAMED04719881570743 EUDAMED04719880833139 EUDAMED04719880834464 EUDAMED04719881570767 EUDAMED04719881570668 EUDAMED04719880833061 EUDAMED04719880833146 EUDAMED
- Basic UDI-DI
- 47198815612VL EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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
Category: Orthodontic tube
C-Cb-02 by MEM Dental Technology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180952 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 47198815612VL | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEM Dental Technology Co., Ltd
- EUDAMED SRN
- TW-MF-000003514
- Authorised Representative
- Meimen Engineering Manufacturer AB SE-AR-000002115
Sources (18)
- EUDAMED cbe0e07c-8be3-4f04-9537-f67398d520f2 61 fields · synced Sep 18, 2026
- EUDAMED b3ad511c-56c5-4b25-98f9-b9a46550e3bd 61 fields · synced May 16, 2026
- EUDAMED cf5c2dd6-a588-4348-b55c-5d19d8e883fa 61 fields · synced May 17, 2026
- EUDAMED efd45325-f4d6-4e63-aea9-1945efcba1f8 61 fields · synced May 17, 2026
- EUDAMED fd195813-982d-435e-bc4f-bc599f7cbd98 61 fields · synced May 17, 2026
- EUDAMED e3a0278a-b1a8-4190-8b16-5c5211d2a8b0 61 fields · synced May 17, 2026
- EUDAMED cf406f98-f88b-43ed-a392-d69158f0e3d6 61 fields · synced May 17, 2026
- EUDAMED b827e2d1-80fb-441f-94f2-388c7d88c616 61 fields · synced May 17, 2026
- EUDAMED 6b360ff6-b7a7-4701-a6c5-2cf25014fc48 61 fields · synced May 17, 2026
- EUDAMED 7093bcc4-04bd-4468-879e-3467ff7a652a 61 fields · synced May 19, 2026
- EUDAMED 1e138f8a-d10b-402b-892c-992f3191bf4a 61 fields · synced May 19, 2026
- EUDAMED 4a9e3ae2-b18e-4071-a276-3f8b173066f4 61 fields · synced May 19, 2026
- EUDAMED b0842a57-b692-464f-bcac-3f0ef794c6c5 61 fields · synced May 19, 2026
- EUDAMED 5138fdc5-a762-40fb-ad62-c615721be915 61 fields · synced May 19, 2026
- EUDAMED efde243d-5265-45d1-9475-ac29d97d5560 61 fields · synced May 19, 2026
- EUDAMED de142dc8-3531-4d41-9007-24182a0bfb1b 61 fields · synced May 19, 2026
- EUDAMED 913a599a-9738-4dfd-98be-faf34e21c8a8 61 fields · synced May 19, 2026
- FDA 510(k) K180952 1 fields · synced May 18, 2026