Identity
- Model / Reference
- MK400L EUDAMEDMK4L250-FB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809802641266 EUDAMED
- Basic UDI-DI
- B-08809802641266 EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mk4l250-Fb by Daesung Maref Co., Ltd. — 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-08809802641266 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
- EUDAMED SRN
- KR-MF-000008616
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 25e22e1b-8089-405d-add6-ae4e23f9b61c 61 fields · synced Jun 18, 2026