- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 27, 2025
081016109NeoChromesUBIOT Neochromes Hard Resin UC SFSV Gray 8 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Advanced Photochromics LLC. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000043049(01)10810161090164
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Spain; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jun 1, 2021 | Still on market |
| Cyprus | Jan 2, 2023 | Still on market |
| Germany | Apr 1, 2023 | Still on market |
| France | Mar 1, 2024 | Still on market |
| Italy | Sep 1, 2023 | Still on market |
| Lithuania | Apr 1, 2022 | Still on market |
| Poland | Aug 1, 2023 | Still on market |
| Portugal | Sep 1, 2022 | Still on market |
| Romania | Dec 1, 2023 | Still on market |
| Türkiye | May 1, 2024 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
10810161090164Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081016109NeoChromesUB0265007393UDI 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.
2 packaging levels registered — each level carries its own UDI-DI.
10810161090164× 1 unitBase unit20810161090161× 40 units30810161090168× 3 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
Q0210010101MONOFOCAL ORGANIC OPHTHALMIC LENSESPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.081016109NeoChromesUBOn the marketIOT Neochromes Hard Resin UC SFSV Gray 6081016109NeoChromesUBOn the marketIOT Neochromes Hard Resin UC SFSV Gray 7081016109NeoChromesUBOn the marketIOT Neochromes HI 1.60 UC Camber Brown 0.5081016109NeoChromesUBOn the marketIOT Neochromes HI 1.60 UC Camber Brown 2081016109NeoChromesUBOn the marketIOT Neochromes HI 1.60 UC Camber Brown 3081016109NeoChromesUBOn the marketNo certificate specifically references this device's Basic UDI-DI.