Identity
- Trade Name
- Multi-unit Lab Analog EUDAMED
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMED
- Model / Reference
- MLA450 EUDAMEDMLA550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041356539 EUDAMED08800041356546 EUDAMED
- Basic UDI-DI
- 8800041300003014W EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Multi-unit Lab Analog by SEWONMEDIX Inc. — Class I — 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 | 8800041300003014W | Class I | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 94402b36-65d2-4f93-89a1-63b585269780 61 fields · synced Jul 13, 2026
- EUDAMED 4abe53cb-c3e3-4047-b7e2-36b60e01c144 61 fields · synced May 17, 2026