← Back to catalogue
Traumex
EUDAMEDClass IIb (EU MDR)
Ref BT509.S10Model 3.5 mm Small Dynamic Compression Plate, 7 Holes
Identity
- Trade Name
- TRAUMEX EUDAMED
- Device Name
- Bone Plate EUDAMED
- Model / Reference
- 3.5 mm Small Dynamic Compression Plate, 7 Holes EUDAMEDBT509.S10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G562BT509S100 EUDAMED
- Basic UDI-DI
- ++G562BPBL EUDAMED
- Direct Marketing DI
- G562BT509S100 EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - 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 | ++G562BPBL | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonetech Medisys Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000020462
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 3191ce7d-bd60-447c-8ac6-932adace81b6 61 fields · synced Jun 19, 2026