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bracket
EUDAMEDClass IIa (EU MDR)
Ref 8816-15BModel Roth bracketsRef 8216-23KRef 82K6-25ERef 8154-21BModel Edgewise bracketsRef 8215-10HRef 8217-23ERef 8118-23BRef 8316-10BModel MBT bracketsRef 8317-25HModel MBT* bracketsRef E82H5-23HRef E82H5-20HRef 8315-15HRef 821G-10ERef 8377-23CModel MBT brackets Ref 82M3-20IRef 8154-10BRef 8253-11B-46Ref 8154-10B-16Ref 8315-20KRef 8315-15ERef 8154-11B-26Ref 8115-15BRef 8154-11BRef 8118-20BRef 8215-14HRef 8353-20B-26Ref 8277-15CRef 8378-20CRef 8354-20B-26Ref 8218-23KRef 8278-13CRef 8215-25KRef 83M3-25IModel MBT*bracketsRef 8153-11B-36Ref 831G-10ERef 8215-20BRef 821G-15ERef 8354-21B-36Ref 8216-25BRef 8354-10B-16Ref 8815-20BRef 8216-10BRef 8317-10HRef 8817-20BRef 8217-23HRef 8315-10KRef 8817-13BRef 8215-10ERef 8354-20B-46Ref 8317-10KRef 8215-20H
Identity
- Device Name
- bracket EUDAMED
- Model / Reference
- Roth brackets EUDAMED8816-15B EUDAMED8216-23K EUDAMED82K6-25E EUDAMEDEdgewise brackets EUDAMED8154-21B EUDAMED8215-10H EUDAMED8217-23E EUDAMED8118-23B EUDAMEDMBT brackets EUDAMED8316-10B EUDAMEDMBT* brackets EUDAMED8317-25H EUDAMEDE82H5-23H EUDAMEDE82H5-20H EUDAMED8315-15H EUDAMED821G-10E EUDAMED8377-23C EUDAMED82M3-20I EUDAMED8154-10B EUDAMED8253-11B-46 EUDAMED8154-10B-16 EUDAMED8315-20K EUDAMED8315-15E EUDAMED8154-11B-26 EUDAMED8115-15B EUDAMED8154-11B EUDAMED8118-20B EUDAMED8215-14H EUDAMED8353-20B-26 EUDAMED8277-15C EUDAMED8378-20C EUDAMED8354-20B-26 EUDAMED8218-23K EUDAMED8278-13C EUDAMED8215-25K EUDAMEDMBT*brackets EUDAMED83M3-25I EUDAMED8153-11B-36 EUDAMED831G-10E EUDAMED8215-20B EUDAMED821G-15E EUDAMED8354-21B-36 EUDAMED8216-25B EUDAMED8354-10B-16 EUDAMED8815-20B EUDAMED8216-10B EUDAMED8317-10H EUDAMED8817-20B EUDAMED8217-23H EUDAMED8315-10K EUDAMED8817-13B EUDAMED8215-10E EUDAMED8354-20B-46 EUDAMED8317-10K EUDAMED8215-20H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054770345 EUDAMED06942054772325 EUDAMED06942054772608 EUDAMED06942054771526 EUDAMED06942054769639 EUDAMED06942054772011 EUDAMED06942054771465 EUDAMED06942054771007 EUDAMED06942054773117 EUDAMED06942054771953 EUDAMED06942054771946 EUDAMED06942054770666 EUDAMED06942054770130 EUDAMED06942054773353 EUDAMED06942054772035 EUDAMED06942054769448 EUDAMED06942054770499 EUDAMED06942054769547 EUDAMED06942054772950 EUDAMED06942054770840 EUDAMED06942054769592 EUDAMED06942054769318 EUDAMED06942054769455 EUDAMED06942054771458 EUDAMED06942054769684 EUDAMED06942054773759 EUDAMED06942054770048 EUDAMED06942054773674 EUDAMED06942054773834 EUDAMED06942054772400 EUDAMED06942054770307 EUDAMED06942054771786 EUDAMED06942054773254 EUDAMED06942054769523 EUDAMED06942054770970 EUDAMED06942054771694 EUDAMED06942054770154 EUDAMED06942054773889 EUDAMED06942054772288 EUDAMED06942054771281 EUDAMED06942054772189 EUDAMED06942054770161 EUDAMED06942054770697 EUDAMED06942054772219 EUDAMED06942054771830 EUDAMED06942054770604 EUDAMED06942054770093 EUDAMED06942054769905 EUDAMED06942054773858 EUDAMED06942054770703 EUDAMED06942054771700 EUDAMED
- Basic UDI-DI
- B-06942054770345 EUDAMEDB-06942054772325 EUDAMEDB-06942054772608 EUDAMEDB-06942054771526 EUDAMEDB-06942054769639 EUDAMEDB-06942054772011 EUDAMEDB-06942054771465 EUDAMEDB-06942054771007 EUDAMEDB-06942054773117 EUDAMEDB-06942054771953 EUDAMEDB-06942054771946 EUDAMEDB-06942054770666 EUDAMEDB-06942054770130 EUDAMEDB-06942054773353 EUDAMEDB-06942054772035 EUDAMEDB-06942054769448 EUDAMEDB-06942054770499 EUDAMEDB-06942054769547 EUDAMEDB-06942054772950 EUDAMEDB-06942054770840 EUDAMEDB-06942054769592 EUDAMEDB-06942054769318 EUDAMEDB-06942054769455 EUDAMEDB-06942054771458 EUDAMEDB-06942054769684 EUDAMEDB-06942054773759 EUDAMEDB-06942054770048 EUDAMEDB-06942054773674 EUDAMEDB-06942054773834 EUDAMEDB-06942054772400 EUDAMEDB-06942054770307 EUDAMEDB-06942054771786 EUDAMEDB-06942054773254 EUDAMEDB-06942054769523 EUDAMEDB-06942054770970 EUDAMEDB-06942054771694 EUDAMEDB-06942054770154 EUDAMEDB-06942054773889 EUDAMEDB-06942054772288 EUDAMEDB-06942054771281 EUDAMEDB-06942054772189 EUDAMEDB-06942054770161 EUDAMEDB-06942054770697 EUDAMEDB-06942054772219 EUDAMEDB-06942054771830 EUDAMEDB-06942054770604 EUDAMEDB-06942054770093 EUDAMEDB-06942054769905 EUDAMEDB-06942054773858 EUDAMEDB-06942054770703 EUDAMEDB-06942054771700 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
bracket by Zhejiang Shinye Medical Technology Corp. , Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942054770345 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Shinye Medical Technology Corp. , Ltd.
- EUDAMED SRN
- CN-MF-000023934
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (51)
- EUDAMED 3b789c3d-ec30-48e7-a748-a003d45c913c 61 fields · synced Oct 5, 2026
- EUDAMED 445210e7-50a9-4702-ac23-5db72bb85dc4 61 fields · synced May 11, 2026
- EUDAMED 71bd7440-d8d5-496e-beb2-95c20fd8b815 61 fields · synced May 11, 2026
- EUDAMED 71167717-a4a7-4c6f-9e3a-16570755ba01 61 fields · synced May 11, 2026
- EUDAMED 76eb3985-5b46-4679-a948-2895042e1c5d 61 fields · synced May 11, 2026
- EUDAMED 7d215d8f-6387-4e42-8527-f9a2b43ea3f6 61 fields · synced May 11, 2026
- EUDAMED 9470350f-4b20-41e5-948a-1e74fb8d6bd0 61 fields · synced May 11, 2026
- EUDAMED b51e64c3-c74a-4ee8-a3f4-4b461087198b 61 fields · synced May 11, 2026
- EUDAMED ce1ee23f-c111-4575-9c50-5b07d53c3725 61 fields · synced May 11, 2026
- EUDAMED f67d6b3b-0aec-4630-ae9d-8c32a8817cc5 61 fields · synced May 11, 2026
- EUDAMED 004ddec5-5f93-4997-969d-76144a6b77c2 61 fields · synced May 11, 2026
- EUDAMED 09d9d996-d298-487b-8ae4-46f26268ee03 61 fields · synced May 11, 2026
- EUDAMED 1a95f342-26bb-4aea-966a-3d45750a553a 61 fields · synced May 11, 2026
- EUDAMED c5618df9-d228-4b00-9f43-9fb5ceb3cf0d 61 fields · synced May 16, 2026
- EUDAMED 5c97ad7f-e1b4-4e54-b99a-4009e7a513fd 61 fields · synced May 16, 2026
- EUDAMED 2c4da3a9-1ebe-44a9-b75c-5b3bde0d6221 61 fields · synced May 16, 2026
- EUDAMED 09395b08-c61d-4da5-9b27-f98c28fe9a2f 61 fields · synced May 16, 2026
- EUDAMED e8fa8124-0e8c-4623-9be4-101f5a9db2e4 61 fields · synced May 16, 2026
- EUDAMED 53749739-20cd-46cd-907e-b63baaaa7a5a 61 fields · synced May 16, 2026
- EUDAMED f077784d-9037-44df-a686-364f43f695c3 61 fields · synced May 16, 2026
- EUDAMED 8907045e-4c88-41cb-9027-ac03c4569076 61 fields · synced May 16, 2026
- EUDAMED 9bca9d26-f19b-4583-a936-9b9735e8aa90 61 fields · synced May 16, 2026
- EUDAMED 1d154631-abe9-4c91-a028-2aa6b94b6ec5 61 fields · synced May 16, 2026
- EUDAMED c707e23e-1099-4f13-b8cf-1766ba44e655 61 fields · synced May 16, 2026
- EUDAMED 4e47b270-7749-4733-8775-31d8627db70c 61 fields · synced May 16, 2026
- EUDAMED 2d0b6e57-092f-4283-99d1-1ac4911d06e0 61 fields · synced May 16, 2026
- EUDAMED 635df631-ea96-4938-ae22-2f9be3bb3f6b 61 fields · synced May 16, 2026
- EUDAMED 8d121e6f-958f-415c-a281-0dca120e02d0 61 fields · synced May 16, 2026
- EUDAMED 1c07d89b-331d-473b-8756-6920c1528237 61 fields · synced May 16, 2026
- EUDAMED 2ff72c2f-a56f-4985-8b8b-79d4f5d560c4 61 fields · synced May 16, 2026
- EUDAMED a0872bf5-dd4b-4f99-a940-9fee72dcbf05 61 fields · synced May 16, 2026
- EUDAMED 4bfed04d-7273-4f8a-90ad-7996c05feca8 61 fields · synced May 16, 2026
- EUDAMED 7aff6c6e-6a46-454e-b819-2a31a66031e2 61 fields · synced May 16, 2026
- EUDAMED fdcaaab8-9efb-4d6f-bf66-19f30b215ee9 61 fields · synced May 16, 2026
- EUDAMED b8af1ea2-95ab-4ea6-8537-c25180730d5b 61 fields · synced May 16, 2026
- EUDAMED d0ecbfeb-dc06-45a7-acdd-89fbf333eeba 61 fields · synced May 16, 2026
- EUDAMED 6ae80354-41ea-4619-8164-2595f0df0516 61 fields · synced May 16, 2026
- EUDAMED 4bac5aeb-39ea-44a0-8992-5a57b72a766c 61 fields · synced May 16, 2026
- EUDAMED 517c50f6-39ee-4b3a-93e7-abb257e58831 61 fields · synced May 16, 2026
- EUDAMED 93a3e2f6-8d38-4d6d-9bf2-537a30771e37 61 fields · synced May 16, 2026
- EUDAMED 6c6e2b47-aeb3-46e3-99cb-aef2089c7581 61 fields · synced May 16, 2026
- EUDAMED 39b1a59e-615f-428d-8ce8-d25f42d2f181 61 fields · synced May 16, 2026
- EUDAMED 93abe09e-9a5a-48d9-92d7-0281a17215cb 61 fields · synced May 16, 2026
- EUDAMED e69f11df-a5a4-4b84-9be4-c89fc59d8ca6 61 fields · synced May 16, 2026
- EUDAMED ad919cbe-bd16-4545-830a-f59359230698 61 fields · synced May 16, 2026
- EUDAMED c9b8d45e-3c33-4e8d-baba-95de67fc63db 61 fields · synced May 16, 2026
- EUDAMED e2a98444-38e9-4152-899a-3919477f9b35 61 fields · synced May 16, 2026
- EUDAMED be2a2b45-d5d9-4286-8ff0-a783267fe042 61 fields · synced May 17, 2026
- EUDAMED adce11c6-fb83-4d27-857b-1c99ef38a1bd 61 fields · synced May 17, 2026
- EUDAMED 1979800b-bb5d-4e43-a799-aa283e7d6dda 61 fields · synced May 17, 2026
- EUDAMED 068159a6-a8d1-4d39-8f9c-a6abf8dc48b3 61 fields · synced May 17, 2026