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Paragon High Offset Porous+ha Coated Stem Size2
EUDAMEDClass III (EU MDR)
Ref 63.1162Model PARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE2
Identity
- Trade Name
- PARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE2 EUDAMED
- Device Name
- PARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE2 EUDAMED
- Model / Reference
- PARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE2 EUDAMED63.1162 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659114827 EUDAMED
- Basic UDI-DI
- B-05051659114827 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 Porous+ha Coated Stem Size2 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-05051659114827 | 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 6eca9c08-ce52-4829-9e0c-224ddd228bea 61 fields · synced Oct 6, 2026