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Paragon Standard Porous Coated Stem
EUDAMEDClass III (EU MDR)
Ref 63.1002Model PARAGON STANDARD POROUS COATED STEM SIZE2
Identity
- Device Name
- PARAGON STANDARD POROUS COATED STEM EUDAMED
- Model / Reference
- PARAGON STANDARD POROUS COATED STEM SIZE2 EUDAMED63.1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051659113622 EUDAMED
- Basic UDI-DI
- B-05051659113622 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 Porous Coated Stem 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-05051659113622 | 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 c73c11e8-e66c-41b5-81f3-1e186e8c65a5 61 fields · synced Jun 19, 2026