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EUDAMED last updated this device on Jul 20, 2026
843603552AESP00202RKDatospir Touch Diagnostic-F is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SIBEL SAU. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0843603552389409881ES-MF-000000287(01)08436035523894
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 | Jun 23, 2026 | Still on market |
| Bulgaria | Jun 23, 2026 | Still on market |
| Cyprus | Jun 23, 2026 | Still on market |
| EL | Jun 23, 2026 | Still on market |
| France | Jun 23, 2026 | Still on market |
| Italy | Jun 23, 2026 | Still on market |
| Poland | Jun 23, 2026 | Still on market |
| Portugal | Jun 23, 2026 | Still on market |
| Romania | Jun 23, 2026 | Still on market |
| Türkiye | Jun 23, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12150101CLINICAL/DIAGNOSTIC SPIROMETERSPrimary 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.
2024 CR 0025SupplementedNotified 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 →843603552AESP00302RQOn the marketDatospir Aira T843603552AESP00302RQOn the marketDatospir Touch Diagnostic-D843603552AESP00202RKOn the marketDatospir Touch Diagnostic-T843603552AESP00202RKOn the marketDatospir Touch Easy-D843603552AESP00202RKOn the marketDatospir Touch Easy-F843603552AESP00202RKOn the marketNo certificate specifically references this device's Basic UDI-DI.