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DE-MF-0000084441000297126PRO1-K1-05-220-35 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by FUJIFILM medwork 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 Jan 20, 2026
4044503060493WPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04044503035226
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
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 | Dec 11, 2025 | Still on market |
| Austria | Dec 11, 2025 | Still on market |
| Belgium | Dec 11, 2025 | Still on market |
| Bulgaria | Dec 11, 2025 | Still on market |
| Cyprus | Dec 11, 2025 | Still on market |
| Czechia | Dec 11, 2025 | Still on market |
| Denmark | Dec 11, 2025 | Still on market |
| Estonia | Dec 11, 2025 | Still on market |
| EL | Dec 11, 2025 | Still on market |
| Spain | Dec 11, 2025 | Still on market |
| Finland | Dec 11, 2025 | Still on market |
| France | Dec 11, 2025 | Still on market |
| Croatia | Dec 11, 2025 | Still on market |
| Hungary | Dec 11, 2025 | Still on market |
| Ireland | Dec 11, 2025 | Still on market |
| Iceland | Dec 11, 2025 | Still on market |
| Italy | Dec 11, 2025 | Still on market |
| Liechtenstein | Dec 11, 2025 | Still on market |
| Lithuania | Dec 11, 2025 | Still on market |
| Luxembourg | Dec 11, 2025 | Still on market |
| Latvia | Dec 11, 2025 | Still on market |
| Malta | Dec 11, 2025 | Still on market |
| Netherlands | Dec 11, 2025 | Still on market |
| Norway | Dec 11, 2025 | Still on market |
| Poland | Dec 11, 2025 | Still on market |
| Portugal | Dec 11, 2025 | Still on market |
| Romania | Dec 11, 2025 | Still on market |
| Sweden | Dec 11, 2025 | Still on market |
| Slovenia | Dec 11, 2025 | Still on market |
| Slovakia | Dec 11, 2025 | Still on market |
| Türkiye | Dec 11, 2025 | Still on market |
| XI | Dec 11, 2025 | 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.
04044503035226Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4044503060493W70100146797UDI 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.
04044503035226× 1 unitBase unit14044503035223× 2 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
G030499ERCP AND SPHINCTEROTOMY DEVICES - OTHERCertificate health across this manufacturer's portfolio.
1000297126Supplemented1000297126IssuedNotified 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.
View in glossary →Notified 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.
View in glossary →