Identity
- Trade Name
- INTREX EUDAMED
- Device Name
- INTRAMEDULLARY NAILS EUDAMED
- Model / Reference
- Cannulated Humerus Nail EUDAMEDBN105.T09.38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BN105T09380 EUDAMED
- Basic UDI-DI
- ++G562INC5 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Intrex by Bonetech Medisys Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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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 | ++G562INC5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bonetech Medisys Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000020462
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 4adacd2c-3daa-4d33-8bec-e3e50a828cec 61 fields · synced Jun 18, 2026