← Back to catalogue
OrthoPulse 2.0S
EUDAMEDClass IIa (EU MDR)
Ref OPi2S-100 (P/N: 100-018)Model OrthoPulse
Identity
- Trade Name
- OrthoPulse 2.0S EUDAMED
- Device Name
- OrthoPulse® EUDAMED
- Model / Reference
- OrthoPulse EUDAMEDOPi2S-100 (P/N: 100-018) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 91201180900018 EUDAMED
- Basic UDI-DI
- 912011809OPiGN EUDAMED
- Direct Marketing DI
- 91201180900018 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 2.0S 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolux Technology GmbH
- EUDAMED SRN
- AT-MF-000020789
Sources (1)
- EUDAMED 79973e6b-ffe4-4969-8d9d-2d291ea61d6f 61 fields · synced Jun 18, 2026