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BioMIM® Buccal Tubes
EUDAMEDClass IIa (EU MDR)
Ref 907.1066-5Model BM SBT LR 18/-12/0 5PK
Identity
- Trade Name
- BioMIM® Buccal Tubes EUDAMED
- Device Name
- Orthodontic Buccal Tube EUDAMED
- Model / Reference
- BM SBT LR 18/-12/0 5PK EUDAMED907.1066-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840273904441 EUDAMED
- Basic UDI-DI
- B-00840273904441 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
BioMIM® Buccal Tubes by World Class Technology Corporation — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
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-00840273904441 | Class IIa | Active |
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Manufacturer
- Manufacturer
- World Class Technology Corporation
- EUDAMED SRN
- US-MF-000014389
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED f4371294-4a77-4b79-99fa-e14c31a963b8 61 fields · synced Jun 19, 2026