← Back to catalogue
Reconstruction nail +1 more model
EUDAMEDClass IIb (EU MDR)
Ref 397129790121Model NailRef 397129790121S
by MEDIN, a.s.
Identity
- Trade Name
- Reconstruction nail; long, 10×400 mm, 135°, left, cannulated EUDAMEDReconstruction nail sterile; long, 10×400 mm, 135°, left, cannulated EUDAMED
- Device Name
- Reconstruction nail EUDAMEDReconstruction nail sterile EUDAMED
- Model / Reference
- Nail EUDAMED397129790121 EUDAMED397129790121S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591712366536 EUDAMED08591712367458 EUDAMED
- Basic UDI-DI
- 85917126010101V4 EUDAMED85917126010101SNF EUDAMED
- Direct Marketing DI
- 08591712366536 EUDAMED08591712367458 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.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MEDIN, a.s.
- EUDAMED SRN
- CZ-MF-000012371
Sources (2)
- EUDAMED b22d42ed-2868-4478-abbc-c1a0c2cebf88 61 fields · synced Jul 14, 2026
- EUDAMED 47dd2875-68fa-4936-9ebc-f5dbb1f1bb86 61 fields · synced May 17, 2026