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Traumex
EUDAMEDClass IIb (EU MDR)
Ref BT104.T38Model 2.7mm Cortex Screw- Self Tapping
Identity
- Trade Name
- TRAUMEX EUDAMED
- Device Name
- BONE SCREWS EUDAMED
- Model / Reference
- 2.7mm Cortex Screw- Self Tapping EUDAMEDBT104.T38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BT104T380 EUDAMED
- Basic UDI-DI
- ++G562BSBS EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER 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
Traumex 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 | ++G562BSBS | 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 72f16b73-14a9-41d5-8aef-34560b8f02b8 61 fields · synced Jun 19, 2026