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Paragon High Offset Ha Coated Stem Size9
EUDAMEDClass III (EU MDR)
Ref 63.1139Model PARAGON HIGH OFFSET HA COATED STEM SIZE9
Identity
- Trade Name
- PARAGON HIGH OFFSET HA COATED STEM SIZE9 EUDAMED
- Device Name
- PARAGON HIGH OFFSET HA COATED STEM SIZE9 EUDAMED
- Model / Reference
- PARAGON HIGH OFFSET HA COATED STEM SIZE9 EUDAMED63.1139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659114650 EUDAMED
- Basic UDI-DI
- B-05051659114650 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 High Offset Ha Coated Stem Size9 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-05051659114650 | 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 e6a1fcc2-3db6-4a52-9a9c-a2787862f0fa 61 fields · synced Sep 17, 2026