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Reconstruction nail +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129790601Model NailRef 397129790601S
by MEDIN, a.s.
Identity
- Trade Name
- Reconstruction nail; long, 12×420 mm, 135°, left, cannulated EUDAMEDReconstruction nail sterile; long, 12×420 mm, 135°, left, cannulated EUDAMED
- Device Name
- Reconstruction nail EUDAMEDReconstruction nail sterile EUDAMED
- Model / Reference
- Nail EUDAMED397129790601 EUDAMED397129790601S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712399718 EUDAMED08591712399978 EUDAMED
- Basic UDI-DI
- 85917126010101V4 EUDAMED85917126010101SNF EUDAMED
- Direct Marketing DI
- 08591712399718 EUDAMED08591712399978 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- Models / Variants
- Reconstruction nail EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Arthrodesis intramedullary nail, non-distracting
Reconstruction nail +1 more model by MEDIN, a.s. — Class IIb — MDR — listed in EUDAMED — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85917126010101V4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED 554ac1a8-7d44-49e0-bd55-2e05f839e2a1 61 fields · synced Jul 26, 2026
- EUDAMED aa1c5b88-2773-4ca7-a889-ac0a87de1d70 61 fields · synced May 19, 2026