← Back to catalogue
Ent Unit
EUDAMEDClass IIa (EU MDR)
Ref NET-4000/MGSI-CA-ENT UNITModel NET-4000Ref NET-1100/MGSI-CA-ENT UNITModel NET-1100Ref NET-600A / MGSI-CA-ENT UNITModel NET-600ARef NET-4000 / MGSI-CA-ENT UNITRef NET-1100 / MGSI-CA-ENT UNIT
Identity
- Trade Name
- ENT UNIT EUDAMED
- Device Name
- ENT UNIT EUDAMED
- Model / Reference
- NET-4000 EUDAMEDNET-4000/MGSI-CA-ENT UNIT EUDAMEDNET-1100 EUDAMEDNET-1100/MGSI-CA-ENT UNIT EUDAMEDNET-600A EUDAMEDNET-600A / MGSI-CA-ENT UNIT EUDAMEDNET-4000 / MGSI-CA-ENT UNIT EUDAMEDNET-1100 / MGSI-CA-ENT UNIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800029902533 EUDAMED18800029902472 EUDAMED18800029902489 EUDAMED
- Basic UDI-DI
- B-18800029902533 EUDAMEDB-18800029902472 EUDAMEDB-18800029902489 EUDAMED88000299GTUTL20WB EUDAMED88000299GTUT20PQ EUDAMED88000299GTUTM20WG EUDAMED
- Direct Marketing DI
- 18800029902533 EUDAMED18800029902472 EUDAMED18800029902489 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMEDGreece 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
Ent Unit by Mega Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: ENT Unit
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-18800029902533 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-18800029902533 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mega Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000008718
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (6)
- EUDAMED df93e662-b0af-4893-a9b5-ec5130b2755f 61 fields · synced Jul 20, 2026
- EUDAMED eabe2ddc-5c06-41a5-9b50-83ca3a2bcd9c 61 fields · synced May 17, 2026
- EUDAMED 6f6750e2-e9aa-4e81-b60d-eabc74e9c159 61 fields · synced May 18, 2026
- EUDAMED a676a564-4013-4377-9c83-b5e6decc94f1 61 fields · synced Jun 19, 2026
- EUDAMED ef6fb01f-f031-40c9-a774-9dd7d19574c4 61 fields · synced Jul 12, 2026
- EUDAMED 6db2b90e-9b62-4120-8dc7-d62f0d06debc 61 fields · synced Jul 20, 2026