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US-MF-000002321CL 052098 0016ST80i Stress Test System is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Philips Medical Systems. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 27, 2025
B-00884838094840Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00884838094840
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 Austria; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | May 24, 2013 | Dec 31, 9999 |
| Belgium | May 24, 2013 | Dec 31, 9999 |
| Bulgaria | May 24, 2013 | Dec 31, 9999 |
| Cyprus | May 24, 2013 | Dec 31, 9999 |
| Czechia | May 24, 2013 | Dec 31, 9999 |
| Germany | May 24, 2013 | Dec 31, 9999 |
| Denmark | May 24, 2013 | Dec 31, 9999 |
| Estonia | May 24, 2013 | Dec 31, 9999 |
| EL | May 24, 2013 | Dec 31, 9999 |
| Spain | May 24, 2013 | Dec 31, 9999 |
| Finland | May 24, 2013 | Dec 31, 9999 |
| France | May 24, 2013 | Dec 31, 9999 |
| Croatia | May 24, 2013 | Dec 31, 9999 |
| Hungary | May 24, 2013 | Dec 31, 9999 |
| Ireland | May 24, 2013 | Dec 31, 9999 |
| Italy | May 24, 2013 | Dec 31, 9999 |
| Lithuania | May 24, 2013 | Dec 31, 9999 |
| Luxembourg | May 24, 2013 | Dec 31, 9999 |
| Latvia | May 24, 2013 | Dec 31, 9999 |
| Malta | May 24, 2013 | Dec 31, 9999 |
| Netherlands | May 24, 2013 | Dec 31, 9999 |
| Poland | May 24, 2013 | Dec 31, 9999 |
| Portugal | May 24, 2013 | Dec 31, 9999 |
| Romania | May 24, 2013 | Dec 31, 9999 |
| Sweden | May 24, 2013 | Dec 31, 9999 |
| Slovenia | May 24, 2013 | Dec 31, 9999 |
| Slovakia | May 24, 2013 | Dec 31, 9999 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00884838094840Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-00884838094840860343UDI 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.
Z12050101STRESS ANALYSIS SYSTEMSNo certificate specifically references this device's Basic UDI-DI.
0884838BM340SMOn the marketSOLID GEL ECG ELECTRODE, 5/POUCH0884838BM340SMOn the marketSPU 6leadAAMI cable0884838BM343STOn the marketStandard 10-lead Patient Cable IEC0884838BM511SQOn the marketTC ADDITIONAL LEADS KIT: IEC0884838BM511SQOn the marketTC ADDITIONAL LONG LEADS KIT: IEC0884838BM511SQOn the marketNo 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.