← Back to catalogue
Bondable Self-Ligating
EUDAMEDClass IIa (EU MDR)
Ref SLM-2226Ref SLM-2216 Ref SLM-2246
Identity
- Trade Name
- Bondable Self-Ligating EUDAMED
- Device Name
- Orthodontic Buccal Tubes EUDAMED
- Model / Reference
- SLM-2226 EUDAMEDSLM-2216 EUDAMEDSLM-2246 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673549059 EUDAMED06941673546317 EUDAMED06941673546713 EUDAMED
- Basic UDI-DI
- 69416735BT735M9 EUDAMED
- Direct Marketing DI
- 06941673549059 EUDAMED06941673546317 EUDAMED06941673546713 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER 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
Bondable Self-Ligating 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 | 69416735BT735M9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (3)
- EUDAMED 1df81ce6-b856-4b50-b36d-add89d580ae9 61 fields · synced Jul 26, 2026
- EUDAMED 2d37f5e8-fff9-4a75-910f-e7f11b4d1d1d 61 fields · synced May 18, 2026
- EUDAMED 36e97d2f-fd25-40b8-9704-9e378dcc7b1f 61 fields · synced May 19, 2026