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Paragon Standard Ha Coated Stem Size4
EUDAMEDClass III (EU MDR)
Ref 63.1034Model PARAGON STANDARD HA COATED STEM SIZE4
Identity
- Trade Name
- PARAGON STANDARD HA COATED STEM SIZE4 EUDAMED
- Device Name
- PARAGON STANDARD HA COATED STEM SIZE4 EUDAMED
- Model / Reference
- PARAGON STANDARD HA COATED STEM SIZE4 EUDAMED63.1034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659113882 EUDAMED
- Basic UDI-DI
- B-05051659113882 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 Ha Coated Stem Size4 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-05051659113882 | Class III | Active |
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Manufacturer
- Manufacturer
- Covision Medical Technologies Ltd.
- EUDAMED SRN
- GB-MF-000025081
- Authorised Representative
- Covision Medical Technologies (Ireland) Limited IE-AR-000031129
Sources (1)
- EUDAMED dcc5a4e5-71f3-42ef-a1f7-b1d691ec0a5c 61 fields · synced Oct 7, 2026