- Role
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- Date of registration
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EUDAMED last updated this device on Apr 22, 2026
081016109167SFSVOneJYNeochromes ONE HI 1.67 UC SFSV Gray 9 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)18404975005845
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 | May 1, 2026 | Still on market |
| Cyprus | May 1, 2026 | Still on market |
| Germany | May 1, 2026 | Still on market |
| France | May 1, 2026 | Still on market |
| Italy | May 1, 2026 | Still on market |
| Lithuania | May 1, 2026 | Still on market |
| Poland | May 1, 2026 | Still on market |
| Portugal | May 1, 2026 | Still on market |
| Romania | May 1, 2026 | Still on market |
| Türkiye | May 1, 2026 | 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.
18404975005845Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081016109167SFSVOneJY0265022020UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
18404975005845× 1 unitBase unit28404975005842× 40 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.081016109167SFSVOneJYOn the marketNeochromes ONE HI 1.67 UC SFSV Gray 7081016109167SFSVOneJYOn the marketNeochromes ONE HI 1.67 UC SFSV Gray 8081016109167SFSVOneJYOn the marketNeochromes ONE Poly HC SFSV Brown 0.50081016109PolySFSVOneBJOn the marketNeochromes ONE Poly HC SFSV Brown 1081016109PolySFSVOneBJOn the marketNeochromes ONE Poly HC SFSV Brown 2081016109PolySFSVOneBJOn the marketNo certificate specifically references this device's Basic UDI-DI.