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EUDAMED last updated this device on Feb 3, 2026
697003421USWWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →US31E-12-EU is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shanghai Anqing Medical Instrument Co., Ltd. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →06970034210628Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →697003421USWWUS31E-12-EUUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →(01)06970034210628
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12020713URETERORENOSCOPES4 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW001CW007Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Sweden; available across 23 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Oct 21, 2022 | Still on market |
| Austria | Sep 19, 2022 | Still on market |
| Belgium | Oct 18, 2022 | Still on market |
| Cyprus | Sep 1, 2025 | Still on market |
| Czechia | Jan 3, 2023 | Still on market |
| Germany | Sep 14, 2022 | Still on market |
| Denmark | Nov 22, 2022 | Still on market |
| Estonia | Oct 23, 2023 | Still on market |
| EL | Sep 4, 2023 | Still on market |
| Spain | Nov 25, 2022 | Still on market |
| Finland | Sep 21, 2022 | Still on market |
| France | Dec 13, 2022 | Still on market |
| Hungary | May 14, 2025 | Still on market |
| Ireland | Oct 11, 2022 | Still on market |
| Italy | Sep 8, 2022 | Still on market |
| Malta | May 19, 2023 | Still on market |
| Netherlands | Sep 26, 2022 | Still on market |
| Norway | Mar 12, 2025 | Still on market |
| Poland | Jan 16, 2023 | Still on market |
| Portugal | Jan 10, 2023 | Still on market |
| Romania | Aug 15, 2023 | Still on market |
| Türkiye | Sep 21, 2023 | Still on market |
| XI | Feb 27, 2024 | Still on market |
CN-MF-000008487No 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.