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TECHNOLAS TENEO 317 Model 2 w/ SIRIUS+
EUDAMEDClass IIb (EU MDR)
Ref 70010018TPV
Identity
- Trade Name
- TECHNOLAS TENEO 317 Model 2 w/ SIRIUS+ EUDAMED
- Device Name
- TECHNOLAS TENEO 317 Model 2 w/ Diagnostic EUDAMED
- Model / Reference
- 70010018TPV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050555106289 EUDAMED
- Basic UDI-DI
- 4050555B00099K EUDAMED
- EMDN Code
- Z12011001 EXCIMER SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Acquisition and processing of diagnostic data to treat refractive errors referred to an abnormal refractive condition (myopia (ICD-10: H52.1), hyperopia (ICD-10: H52.0), presbyopia (ICD-10: H52.4), with or without astigmatism ICD-10: H52.2.) of the eye in which images fail to focus upon the retina. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
TECHNOLAS TENEO 317 Model 2 w/ SIRIUS+ by Technolas Perfect Vision GmbH — Class IIb — 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 | 4050555B00099K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Technolas Perfect Vision GmbH
- EUDAMED SRN
- DE-PR-000042693
Sources (1)
- EUDAMED 8039db57-1eba-47c2-82d2-3a2ff07865d6 61 fields · synced Jul 14, 2026