← Back to catalogue
MedK Introducer Sets
EUDAMEDClass IIa (EU MDR)
Ref 982115R2111Model MedK Introducer Sets
by medK GmbH
Identity
- Device Name
- MedK Introducer Sets EUDAMED
- Model / Reference
- MedK Introducer Sets EUDAMED982115R2111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B827982115R21111 EUDAMED
- Basic UDI-DI
- B-+B827982115R21111 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa 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 Introducer Sets by medK GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+B827982115R21111 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- medK GmbH
- EUDAMED SRN
- DE-MF-000006273
Sources (1)
- EUDAMED b746f86a-4e2d-4536-8a25-10685a7476e6 61 fields · synced Sep 17, 2026