Keramikkopf Delta 32 XL
by Falcon Medical Medizinische Spezialprodukte GmbH
Ref 10-0007-324Model Implantate Klasse III Kopf Metall - Keramik
Active
CE MDR
Valid until
3 Aug 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9010030-13-03-10000101YY 09010098000074 | Date14 Aug 2026 | StatusActive |
Certificates
- D4007300015 Active
Technical documentation EU MDR
- Certifier
- mdc medical device certification GmbH 0483
- Issued
- 4 Aug 2026
- Expires
- 3 Aug 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
Specification
- Model / Reference
- Implantate Klasse III Kopf Metall - Keramik, 10-0007-324
- Primary DI / UDI-DI
- 09010098000074
- Basic UDI-DI
- 9010030-13-03-10000101YY
- EMDN Code
- P090804050201 Ceramic femoral heads, total hip replacement
- Device Class
- Class III
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000001607
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Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No