Identity
- Trade Name
- INTREX EUDAMED
- Device Name
- INTRAMEDULLARY NAILS EUDAMED
- Model / Reference
- Cannulated Humerus Nail EUDAMEDBN101.T67.28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BN101S67280 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
Intrex by Bonetech Medisys Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 a94c4a2a-72bd-47cb-bc64-195a3eb4bed6 61 fields · synced Jun 19, 2026