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TECHNOLAS TENEO 317 Model 2 w/ ANTERION
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 70010022TPVRef 70009800TPV
Identity
- Trade Name
- TECHNOLAS TENEO 317 Model 2 w/ ANTERION EUDAMEDTECHNOLAS TENEO 317 Model 2 EUDAMEDTECHNOLAS TENEO 317 FDA UDI
- Generic Name
- Ophthalmic excimer laser system FDA UDI
- Device Name
- TECHNOLAS TENEO 317 Model 2 w/ Diagnostic EUDAMEDTECHNOLAS TENEO 317 Model 2 EUDAMED
- Model / Reference
- 70010022TPV EUDAMED70009800TPV EUDAMEDModel2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050555106296 EUDAMED04050555004202 EUDAMEDFDA UDI
- Basic UDI-DI
- 4050555B00099K EUDAMEDB-04050555004202 EUDAMED
- FDA Product Code
- LZS FDA UDI
- EMDN Code
- Z12011001 EXCIMER SURGICAL LASER EUDAMEDZ12011010 ARGON/KRYPTON SURGICAL LASER EUDAMED
- GMDN Term
- Ophthalmic excimer laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Market of Registration
- Germany 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
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TECHNOLAS TENEO 317 Model 2 w/ ANTERION by Technolas Perfect Vision GmbH — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4050555B00099K | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4050555B00099K | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Technolas Perfect Vision GmbH
- EUDAMED SRN
- DE-PR-000042693
Sources (3)
- EUDAMED 12b1e4c9-809f-42a2-84c7-3b8bd04dc4db 61 fields · synced Jul 22, 2026
- FDA UDI 90587687-49d8-4c02-b1aa-02b61d89c372 32 fields · synced May 30, 2026
- EUDAMED 336d12a4-f227-4255-929f-2906cbbe9fca 61 fields · synced Jul 22, 2026