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EUDAMED last updated this device on Aug 14, 2026
9010030-13-03-10000101YYCeramic Head Delta 28 S 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-000001607D4007300015(01)09010098000036
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.
09010098000036Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
9010030-13-03-10000101YY10-0007-281UDI 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.
P090804050201CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENTPrimary 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 marketCeramic Head Delta 28 L9010030-13-03-10000101YYOn the marketCeramic Head Delta 28 M9010030-13-03-10000101YYOn the marketCeramic Head Delta 32 L9010030-13-03-10000101YYOn the marketCeramic Head Delta 32 M9010030-13-03-10000101YYOn the marketCeramic Head Delta 32 S9010030-13-03-10000101YYOn the marketCertificate health across this manufacturer's portfolio.
D4007300015IssuedD4007300014IssuedD4007300013IssuedNotified 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 →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 →