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EUDAMED last updated this device on Jul 1, 2026
9010030-11-01-10000111UPSphäricon TPS cup 48B is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by Falcon Medical Medizinische Spezialprodukte GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
AT-MF-000001607D4007300013(01)09010098004201
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 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 Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
09010098004201Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
9010030-11-01-10000111UP11-1004-048UDI 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.
P090803010201PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →9010015-01-01-00100000XFOn the marketSphäricon TPS cup 44A9010030-11-01-10000111UPOn the marketSphäricon TPS cup 46A9010030-11-01-10000111UPOn the marketSphäricon TPS cup 50BB9010030-11-01-10000111UPOn the marketSphäricon TPS cup 52BB9010030-11-01-10000111UPOn the marketSphäricon TPS cup 54C9010030-11-01-10000111UPOn the marketCertificate health across this manufacturer's portfolio.
D4007300014IssuedD4007300013IssuedNotified 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 →Notified 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 →