Identity
- Trade Name
- IH Fixture Mount EUDAMED
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMED
- Model / Reference
- IHFMR37 EUDAMEDIHFMM35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041302192 EUDAMED08800041302185 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
IH Fixture Mount 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 ec9baccc-e339-4e0b-9d81-07916d1dc47b 61 fields · synced Jul 9, 2026
- EUDAMED b96eba3e-7f1e-44f6-8c08-747df80359ff 61 fields · synced May 18, 2026