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OrthoPulse®
EUDAMEDClass IIa (EU MDR)
Ref OPi-CE101-BTModel OPiL-100Ref OPi2S-100
Identity
- Trade Name
- OrthoPulse® EUDAMED
- Device Name
- OrthoPulse EUDAMEDOrthoPulse 2.0S EUDAMED
- Model / Reference
- OPiL-100 EUDAMEDOPi-CE101-BT EUDAMEDOPi2S-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-9120118090012SH EUDAMED91201180900674 EUDAMED
- Basic UDI-DI
- B-9120118090012SH EUDAMEDB-91201180900674 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
OrthoPulse® by Biolux Technology Gmbh — Class IIa — 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-9120118090012SH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biolux Technology GmbH
- EUDAMED SRN
- AT-MF-000020789
Sources (2)
- EUDAMED abdb3a51-c4fb-48b9-9cfe-7ed66b3ad9ca 61 fields · synced Jul 14, 2026
- EUDAMED b4f7eef8-7784-4565-a8b4-e55887a1c674 61 fields · synced May 18, 2026