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CH-MF-000014374HD 60146857 0001DUOLITH SD1 T-Top is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by STORZ MEDICAL AG. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-07630039100599Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07630039100599
3 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 Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jun 17, 2015 | Dec 31, 2028 |
| Austria | Jun 17, 2015 | Dec 31, 2028 |
| Belgium | Jun 17, 2015 | Dec 31, 2028 |
| Bulgaria | Jun 17, 2015 | Dec 31, 2028 |
| Cyprus | Jun 17, 2015 | Dec 31, 2028 |
| Czechia | Jun 17, 2015 | Dec 31, 2028 |
| Germany | Jun 17, 2015 | Dec 31, 2028 |
| Denmark | Jun 17, 2015 | Dec 31, 2028 |
| Estonia | Jun 17, 2015 | Dec 31, 2028 |
| EL | Jun 17, 2015 | Dec 31, 2028 |
| Spain | Jun 17, 2015 | Dec 31, 2028 |
| Finland | Jun 17, 2015 | Dec 31, 2028 |
| France | Jun 17, 2015 | Dec 31, 2028 |
| Croatia | Jun 17, 2015 | Dec 31, 2028 |
| Hungary | Jun 17, 2015 | Dec 31, 2028 |
| Ireland | Jun 17, 2015 | Dec 31, 2028 |
| Iceland | Jun 17, 2015 | Dec 31, 2028 |
| Liechtenstein | Jun 17, 2015 | Dec 31, 2028 |
| Lithuania | Jun 17, 2015 | Dec 31, 2028 |
| Luxembourg | Jun 17, 2015 | Dec 31, 2028 |
| Latvia | Jun 17, 2015 | Dec 31, 2028 |
| Malta | Jun 17, 2015 | Dec 31, 2028 |
| Netherlands | Jun 17, 2015 | Dec 31, 2028 |
| Norway | Jun 17, 2015 | Dec 31, 2028 |
| Poland | Jun 17, 2015 | Dec 31, 2028 |
| Portugal | Jun 17, 2015 | Dec 31, 2028 |
| Romania | Jun 17, 2015 | Dec 31, 2028 |
| Sweden | Jun 17, 2015 | Dec 31, 2028 |
| Slovenia | Jun 17, 2015 | Dec 31, 2028 |
| Slovakia | Jun 17, 2015 | Dec 31, 2028 |
| Türkiye | Jun 17, 2015 | Dec 31, 2028 |
| XI | Jun 17, 2015 | Dec 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07630039100599Basic 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-0763003910059921362.0100UDI 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.
Z12040203DERMAL REGENERATION EQUIPMENTZ12139001SHOCK WAVE THERAPY EQUIPMENTZ120622MUSCLE STIMULATORSZ12040205VACUUM MEDICATION EQUIPMENTZ12101106NEUROLOGICAL STIMULATORSZ12169004ERECTILE DYSFUNCTION STIMULATORSZ12169002UROLOGICAL STIMULATORSNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 1620952-1SupplementedNotified 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.
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