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MedK Diagnostic Guidewires
EUDAMEDClass III (EU MDR)
Ref 98260AGFC260PTFE032Model MedK Diagnostic Guidewires
by medK GmbH
Identity
- Device Name
- MedK Diagnostic Guidewires EUDAMED
- Model / Reference
- MedK Diagnostic Guidewires EUDAMED98260AGFC260PTFE032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B82798260AGFC260PTFE0321 EUDAMED
- Basic UDI-DI
- ++B82798260LF EUDAMED
- EMDN Code
- C04030102 DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
MedK Diagnostic Guidewires by medK GmbH — Class III — 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 | ++B82798260LF | Class III | Active |
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Manufacturer
- Manufacturer
- medK GmbH
- EUDAMED SRN
- DE-MF-000006273
Sources (1)
- EUDAMED a4cd0389-18e1-4cec-8c3c-578bec8f0d1f 61 fields · synced Jul 8, 2026