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MedK Introducer Sets
EUDAMEDClass IIa (EU MDR)
Ref 982116R3211Model MedK Introducer Sets
by medK GmbH
Identity
- Device Name
- MedK Introducer Sets EUDAMED
- Model / Reference
- MedK Introducer Sets EUDAMED982116R3211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B827982116R32111 EUDAMED
- Basic UDI-DI
- B-+B827982116R32111 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
Category: Interventional radiology percutaneous-access kit, single-use
MedK Introducer Sets by medK GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Interventional radiology percutaneous-access kit, single-use.
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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-+B827982116R32111 | Class IIa | Active |
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Manufacturer
- Manufacturer
- medK GmbH
- EUDAMED SRN
- DE-MF-000006273
Sources (1)
- EUDAMED fc039629-7e60-4c97-8314-cf291b21e5b9 61 fields · synced Jul 15, 2026