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Paragon High Offset Ha Coated Stem Size3
EUDAMEDClass III (EU MDR)
Ref 63.1133Model PARAGON HIGH OFFSET HA COATED STEM SIZE3
Identity
- Trade Name
- PARAGON HIGH OFFSET HA COATED STEM SIZE3 EUDAMED
- Device Name
- PARAGON HIGH OFFSET HA COATED STEM SIZE3 EUDAMED
- Model / Reference
- PARAGON HIGH OFFSET HA COATED STEM SIZE3 EUDAMED63.1133 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659114599 EUDAMED
- Basic UDI-DI
- B-05051659114599 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 Size3 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-05051659114599 | 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 a2f68cc1-4a85-4a65-9d93-b58567ddfdb4 61 fields · synced Oct 6, 2026