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OrthoPulse Lite
EUDAMEDClass IIa (EU MDR)
Ref OPiL-100 (P/N: 100-023)Model OrthoPulse
Identity
- Trade Name
- OrthoPulse Lite EUDAMED
- Device Name
- OrthoPulse® EUDAMED
- Model / Reference
- OrthoPulse EUDAMEDOPiL-100 (P/N: 100-023) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 91201180900032 EUDAMED
- Basic UDI-DI
- 912011809OPiGN EUDAMED
- Direct Marketing DI
- 91201180900032 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY 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
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
OrthoPulse Lite by Biolux Technology Gmbh — 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 | 912011809OPiGN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biolux Technology GmbH
- EUDAMED SRN
- AT-MF-000020789
Sources (1)
- EUDAMED 42e0713f-8e3e-4f43-8689-3b64be58cd85 61 fields · synced Jun 19, 2026