- Role
- Country
- Date of registration
- Address
US-MF-000008456No 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.Set (2) Units 96 Hour Pre-Burned-In Replacement Fluorescent Lamp for Cat. No. 2425-230V1 ETDRS Illuminator Cabinet with Diffuser. is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Precision Vision, Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
081128603FluorBulb8XPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00811286036412
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 Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | 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.
00811286036412Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081128603FluorBulb8X2427D-BI-230V1UDI 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.
Z1212012080INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - HARDWARE ACCESSORIESNo certificate specifically references this device's Basic UDI-DI.
081128603PVChartsLFOn the marketSet (2) Units 96 Hour Pre-Burned-In Replacement Fluorescent Lamp for Cat. No. 2425-120V1 ETDRS Illuminator Cabinet with Diffuser.081128603FluorBulb8XOn the marketSet (2) Units 96 Hour Pre-Burned-In Replacement Fluorescent Lamp for Cat. No. 2425-120V2 ETDRS Illuminator Cabinet with Diffuser.081128603FluorBulb8XOn the marketSet (2) Units 96 Hour Pre-Burned-In Replacement Fluorescent Lamp for Cat. No.2425-230V2 ETDRS Illuminator Cabinet with Diffuser.081128603FluorBulb8XOn the marketSet of : 2715 (1.25%), 2716 (2.5%), 2717 (5%), 2718 (10%), 2719 (25%), & 2712 Black)081128603PVChartsLFOn the marketSimulator Glasses Kit made of Heavy Paperboard, with Seven Common Vision Problems: Central Loss, CMV Retinitis, Peripheral Loss, Hemianopia, Color, Overall Blur, Diabetic Retinopathy081128603Occluder59On the market