- Role
- Country
- Date of registration
- Address
DE-MF-000007094HD 60140657 0001TECHNOLAS TENEO 317 Model 2 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Technolas Perfect Vision GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-04050555004202Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04050555004202
1 warning recorded — scroll inside the panel to see all entries.
OTHER
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Mar 28, 2017 | Dec 31, 2028 |
| Austria | Apr 1, 2017 | Dec 31, 2028 |
| Belgium | Apr 1, 2017 | Dec 31, 2028 |
| Bulgaria | Apr 1, 2017 | Dec 31, 2028 |
| Cyprus | Apr 1, 2017 | Dec 31, 2028 |
| Czechia | Apr 1, 2017 | Dec 31, 2028 |
| Denmark | Apr 1, 2017 | Dec 31, 2028 |
| Estonia | Apr 1, 2017 | Dec 31, 2028 |
| EL | Apr 1, 2017 | Dec 31, 2028 |
| Spain | Apr 1, 2017 | Dec 31, 2028 |
| Finland | Apr 1, 2017 | Dec 31, 2028 |
| France | Apr 1, 2017 | Dec 31, 2028 |
| Croatia | Apr 1, 2017 | Dec 31, 2028 |
| Hungary | Apr 1, 2017 | Dec 31, 2028 |
| Ireland | Apr 1, 2017 | Dec 31, 2028 |
| Iceland | Apr 1, 2017 | Dec 31, 2028 |
| Italy | Apr 1, 2017 | Dec 31, 2028 |
| Liechtenstein | Apr 1, 2017 | Dec 31, 2028 |
| Lithuania | Apr 1, 2017 | Dec 31, 2028 |
| Luxembourg | Apr 1, 2017 | Dec 31, 2028 |
| Latvia | Apr 1, 2017 | Dec 31, 2028 |
| Malta | Apr 1, 2017 | Dec 31, 2028 |
| Netherlands | Apr 1, 2017 | Dec 31, 2028 |
| Norway | Apr 1, 2017 | Dec 31, 2028 |
| Poland | Apr 1, 2017 | Dec 31, 2028 |
| Portugal | Apr 1, 2017 | Dec 31, 2028 |
| Romania | Apr 1, 2017 | Dec 31, 2028 |
| Sweden | Apr 1, 2017 | Dec 31, 2028 |
| Slovenia | Apr 1, 2017 | Dec 31, 2028 |
| Slovakia | Apr 1, 2017 | Dec 31, 2028 |
| Türkiye | Apr 1, 2017 | Dec 31, 2028 |
| XI | Apr 1, 2017 | Dec 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04050555004202Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-0405055500420270009800TPVUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12011010ARGON/KRYPTON SURGICAL LASERB-04050555002086On the marketRMF UPGRADEKIT TENEO M2 SW1.28B-70009804TPVVLOn the marketSeeLyra Kit4050555B00059BOn the marketTECHNOLAS TENEO 317 Model 2 RemanufacturedB-04050555005599On the marketTECHNOLAS TENEO 317 Model2 V14050555B000193On the marketUPGRADE KIT TENEO M2 4TH EDITB-70009806TPVW2On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 1061119-1SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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