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EUDAMED last updated this device on May 14, 2026
697307763LMA04JZNone is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Rmist(Tianjin) Medical Device Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
26973077632307None(01)26973077632307
European Medical Device Nomenclature — the EU product classification assigned to this device.
R01020101LARYNGEAL MASKS, SINGLE-LUMEN1 warning recorded — scroll inside the panel to see all entries.
Due to the potential risk of regurgitation and aspiration, do not use Reinforced Airway Tube with pilot balloon and Reinforced Airway Tube with PIV as a substitute for an endotracheal tube in the following elective or difficult airway patients on a non-emergency pathway: 1. Patients who have not fasted, including patients whose fasting cannot be confirmed. 2. Patients who are grossly or morbidly obese, more than 14 weeks pregnant or emergency and resuscitation situations or any condition associated with delayed gastric emptying, or using opiate medication prior to fasting. The device is also contraindicated in: 3. Adult patients who are unable to understand instructions or cannot adequately answer questions regarding their medical history, since such patients may be contraindicated for the device. 4. The device should not be used in the resuscitation or emergency situation in patients who are not profoundly unconscious and who may resist device insertion.
CN-MF-000010408The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 1, 2025 | Still on market |
| Cyprus | Dec 1, 2025 | Still on market |
| Spain | Dec 1, 2025 | Still on market |
| France | Dec 1, 2025 | Still on market |
| Italy | Dec 1, 2025 | Still on market |
| Poland | Dec 1, 2025 | Still on market |
| Türkiye | Dec 1, 2025 | Still on market |
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.
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 →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 →Basic 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 →UDI 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 →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 →Certificate health across this manufacturer's portfolio.
HZ 2303630-1SupplementedNotified 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 →No certificate specifically references this device's Basic UDI-DI.