Identity
- Trade Name
- Handle medium EUDAMED
- Model / Reference
- Handles EUDAMEDIT03-301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404024307728 EUDAMED
- Basic UDI-DI
- 54040243BASIC0125A EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
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: Orthopaedic guidewire, reusable
Handle medium by Titamed — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic guidewire, reusable.
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- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
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 | 54040243BASIC0125A | Class I | Active |
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Manufacturer
- Manufacturer
- Titamed
- EUDAMED SRN
- BE-MF-000000110
Sources (1)
- EUDAMED c20be5b1-fb87-4f6d-b529-f8c606bd052f 61 fields · synced May 22, 2026