← Back to catalogue
Paragon Standard Porous Coated Stem
EUDAMEDClass III (EU MDR)
Ref 63.1004Model PARAGON STANDARD POROUS COATED STEM SIZE4Ref 63.1003Model PARAGON STANDARD POROUS COATED STEM SIZE3Ref 63.1006Model PARAGON STANDARD POROUS COATED STEM SIZE6Ref 63.1005Model PARAGON STANDARD POROUS COATED STEM SIZE5Ref 63.1009Model PARAGON STANDARD POROUS COATED STEM SIZE9Ref 63.1008Model PARAGON STANDARD POROUS COATED STEM SIZE8
Identity
- Device Name
- PARAGON STANDARD POROUS COATED STEM EUDAMED
- Model / Reference
- PARAGON STANDARD POROUS COATED STEM SIZE4 EUDAMED63.1004 EUDAMEDPARAGON STANDARD POROUS COATED STEM SIZE3 EUDAMED63.1003 EUDAMEDPARAGON STANDARD POROUS COATED STEM SIZE6 EUDAMED63.1006 EUDAMEDPARAGON STANDARD POROUS COATED STEM SIZE5 EUDAMED63.1005 EUDAMEDPARAGON STANDARD POROUS COATED STEM SIZE9 EUDAMED63.1009 EUDAMEDPARAGON STANDARD POROUS COATED STEM SIZE8 EUDAMED63.1008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659113646 EUDAMED05051659113639 EUDAMED05051659113660 EUDAMED05051659113653 EUDAMED05051659113691 EUDAMED05051659113684 EUDAMED
- Basic UDI-DI
- B-05051659113646 EUDAMEDB-05051659113639 EUDAMEDB-05051659113660 EUDAMEDB-05051659113653 EUDAMEDB-05051659113691 EUDAMEDB-05051659113684 EUDAMED
- EMDN Code
- P090804010201 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Paragon Standard Porous Coated Stem by Covision Medical Technologies Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051659113646 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covision Medical Technologies Ltd.
- EUDAMED SRN
- GB-MF-000025081
- Authorised Representative
- Covision Medical Technologies (Ireland) Limited IE-AR-000031129
Sources (6)
- EUDAMED 8329cac1-ce3b-458a-92df-2d45afaaae87 61 fields · synced Aug 3, 2026
- EUDAMED d2ee7561-2d82-45ea-9f99-fe4dc73b7597 61 fields · synced May 17, 2026
- EUDAMED 66daf652-3ca1-49fd-aac0-37d8fe0fb138 61 fields · synced May 17, 2026
- EUDAMED a382955e-2264-4fda-82ab-87519a6b04c1 61 fields · synced May 17, 2026
- EUDAMED eb51249f-179f-4ca7-a014-cc3bef721a46 61 fields · synced May 19, 2026
- EUDAMED e94ae355-c1e0-4258-acf5-82be025c73f9 61 fields · synced May 19, 2026