Vario-Cup System
by Waldemar Link GmbH & Co. KG 6 variants
Ref 99-0055/53Model Bipolar head, uncemented, CoCrMo, UHMWPE
Active
CE MDR
Valid until
9 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-HSP-034001-X7 04026575352890 | Date12 May 2026 | StatusActive |
Certificates
- 13794GB450240710 Active
Technical documentation EU MDR
- Certifier
- DNV MEDCERT GmbH 0482
- Issued
- 10 Jul 2024
- Expires
- 9 Jul 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Vario-Cup System
- Model / Reference
- Bipolar head, uncemented, CoCrMo, UHMWPE, 99-0055/53
- Primary DI / UDI-DI
- 04026575352890
- Basic UDI-DI
- 4026575-1-HSP-034001-X7
- EMDN Code
- P0908040503 Hip prostheses, bi-articular cups
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No