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G-Coating
EUDAMEDClass IIa (EU MDR)
Ref MG21-015HmRef MG21-011Ref MG21-014Ref MG21-031Ref MG21-023HdRef MG21-035Ref MG21-024HmRef MG21-55-3HRef MG21-025Ref MG21-042Ref MG21-021Ref MG21-044Ref MG21-041Ref MG21-045Ref MG21-035HmRef MG21-044HmRef MG21-043HdRef MG21-013HdRef MG21-015Ref MG21-55-345HRef MG21-034HmRef MG21-025HmRef MG21-032Ref MG21-012
Identity
- Trade Name
- G-Coating EUDAMED
- Device Name
- Orthodontic Brackets EUDAMED
- Model / Reference
- MG21-015Hm EUDAMEDMG21-011 EUDAMEDMG21-014 EUDAMEDMG21-031 EUDAMEDMG21-023Hd EUDAMEDMG21-035 EUDAMEDMG21-024Hm EUDAMEDMG21-55-3H EUDAMEDMG21-025 EUDAMEDMG21-042 EUDAMEDMG21-021 EUDAMEDMG21-044 EUDAMEDMG21-041 EUDAMEDMG21-045 EUDAMEDMG21-035Hm EUDAMEDMG21-044Hm EUDAMEDMG21-043Hd EUDAMEDMG21-013Hd EUDAMEDMG21-015 EUDAMEDMG21-55-345H EUDAMEDMG21-034Hm EUDAMEDMG21-025Hm EUDAMEDMG21-032 EUDAMEDMG21-012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673549301 EUDAMED06941673549240 EUDAMED06941673549271 EUDAMED06941673549387 EUDAMED06941673549332 EUDAMED06941673549431 EUDAMED06941673549356 EUDAMED06941673549226 EUDAMED06941673549363 EUDAMED06941673549462 EUDAMED06941673549318 EUDAMED06941673549486 EUDAMED06941673549455 EUDAMED06941673549509 EUDAMED06941673549448 EUDAMED06941673549493 EUDAMED06941673549479 EUDAMED06941673549264 EUDAMED06941673549295 EUDAMED06941673549233 EUDAMED06941673549424 EUDAMED06941673549370 EUDAMED06941673549394 EUDAMED06941673549257 EUDAMED
- Basic UDI-DI
- 69416735BRK735ND EUDAMED
- Direct Marketing DI
- 06941673549301 EUDAMED06941673549240 EUDAMED06941673549271 EUDAMED06941673549387 EUDAMED06941673549332 EUDAMED06941673549431 EUDAMED06941673549356 EUDAMED06941673549226 EUDAMED06941673549363 EUDAMED06941673549462 EUDAMED06941673549318 EUDAMED06941673549486 EUDAMED06941673549455 EUDAMED06941673549509 EUDAMED06941673549448 EUDAMED06941673549493 EUDAMED06941673549479 EUDAMED06941673549264 EUDAMED06941673549295 EUDAMED06941673549233 EUDAMED06941673549424 EUDAMED06941673549370 EUDAMED06941673549394 EUDAMED06941673549257 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
G-Coating by Astar Orthodontics Inc. — Class IIa — 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 | 69416735BRK735ND | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (24)
- EUDAMED dcf9809a-8b84-4662-9023-a54fe941cb60 61 fields · synced Sep 17, 2026
- EUDAMED 4b8aed7c-0ae0-4cd5-bd0d-0079ff9fe01e 61 fields · synced May 16, 2026
- EUDAMED 70fbf235-4568-43bc-8326-4ad3b717c1e0 61 fields · synced May 17, 2026
- EUDAMED 8c041b6d-4ed9-4431-b274-552c0da3b7a9 61 fields · synced May 17, 2026
- EUDAMED c1e27fb1-7ac8-4ee5-9856-b19542a3d33a 61 fields · synced May 17, 2026
- EUDAMED 0bfad57a-f71c-4396-9f65-01927d5242ea 61 fields · synced May 17, 2026
- EUDAMED 67a45d53-d1d2-4116-b066-a5b5fa769539 61 fields · synced May 17, 2026
- EUDAMED 7a77db7b-f559-4422-94a0-1a74de017112 61 fields · synced May 17, 2026
- EUDAMED 5f3d56e7-8a28-4d0d-887f-4d86f4e05c15 61 fields · synced May 17, 2026
- EUDAMED 26d19138-1fee-4b12-9f2e-b8f425d393fb 61 fields · synced May 17, 2026
- EUDAMED 229c47e0-519f-4896-93a2-feaf844771b5 61 fields · synced May 17, 2026
- EUDAMED f3db9ed8-ccba-4f30-b2c0-78b8990ae3fa 61 fields · synced May 18, 2026
- EUDAMED fafef315-5221-4d25-99e6-822845d69a95 61 fields · synced May 18, 2026
- EUDAMED 49f2ee8f-19b9-4510-9eb6-2235ea004ed1 61 fields · synced May 18, 2026
- EUDAMED 0a876978-f2a6-4b93-948e-1daff2bb4862 61 fields · synced May 18, 2026
- EUDAMED c88aa77a-1a15-4158-9e51-681b0fe122b9 61 fields · synced May 18, 2026
- EUDAMED 607c187e-38b3-4c52-a869-c50de728af68 61 fields · synced May 18, 2026
- EUDAMED 6e9c4219-5f8c-4afd-9fb4-92b0e3daf11c 61 fields · synced May 18, 2026
- EUDAMED 7f2c5b94-c1fa-4b91-ab3f-0913568d17a4 61 fields · synced May 18, 2026
- EUDAMED 5da19a16-1e4c-4920-9a73-dcba4f9a7b9d 61 fields · synced May 18, 2026
- EUDAMED ff82b39c-bc45-43b6-a147-0cf01252f5b6 61 fields · synced May 19, 2026
- EUDAMED b11be8a1-a740-4715-ac88-f5b425cd322d 61 fields · synced May 19, 2026
- EUDAMED cac920cd-797e-4ad6-b6f1-a8c7abda033f 61 fields · synced May 19, 2026
- EUDAMED 13e659f2-c0b4-4d98-8726-1ad2e9effd12 61 fields · synced May 19, 2026