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Orthodontic Anchor Screw
EUDAMEDClass IIb (EU MDR)
Ref SL-U2-001Model Special Type
Identity
- Trade Name
- Orthodontic Anchor Screw EUDAMED
- Device Name
- SL-U2 EUDAMED
- Model / Reference
- Special Type EUDAMEDSL-U2-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809744965307 EUDAMED
- Basic UDI-DI
- B-08809744965307 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Orthodontic Anchor Screw by BioMaterials Korea, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809744965307 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BioMaterials Korea, Inc.
- EUDAMED SRN
- KR-MF-000019882
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 8c811cd5-8dce-4d4c-8933-9a1792956da4 61 fields · synced May 23, 2026