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Paragon High Offset Porous Coated Stem Size1
EUDAMEDClass III (EU MDR)
Ref 63.1101Model PARAGON HIGH OFFSET POROUS COATED STEM SIZE1Ref 63.1168Model PARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE8
Identity
- Trade Name
- PARAGON HIGH OFFSET POROUS COATED STEM SIZE1 EUDAMEDPARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE8 EUDAMED
- Device Name
- PARAGON HIGH OFFSET POROUS COATED STEM SIZE1 EUDAMEDPARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE8 EUDAMED
- Model / Reference
- PARAGON HIGH OFFSET POROUS COATED STEM SIZE1 EUDAMED63.1101 EUDAMEDPARAGON HIGH OFFSET POROUS+HA COATED STEM SIZE8 EUDAMED63.1168 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659114339 EUDAMED05051659114889 EUDAMED
- Basic UDI-DI
- B-05051659114339 EUDAMEDB-05051659114889 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 Coated Stem Size1 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-05051659114339 | 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 (2)
- EUDAMED 42ff7326-2039-4aa9-95f4-a09003ac4689 61 fields · synced Jul 20, 2026
- EUDAMED 0c03fcda-3269-41c4-bdd4-3f850758b86c 61 fields · synced May 18, 2026