Identity
- Trade Name
- IH2 Fixture Lab Analog EUDAMEDIH Fixture Lab Analog FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMEDSEWON MEDIX IH Fixture Lab Analog Regular, 3.35x12.0mm FDA UDI
- Model / Reference
- IHFLAR120 EUDAMEDFDA UDI
- Description
- SEWON MEDIX IH Fixture Lab Analog Regular, 3.35x12.0mm FDA UDI
Identifiers
- Catalog Number
- IHFLAR120 FDA UDI
- Primary DI / UDI-DI
- 08800041353088 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800041300003014W EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
IH2 Fixture Lab Analog by SEWONMEDIX Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8800041300003014W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 401b4abf-6e53-411e-a4eb-6784b244a047 61 fields · synced Jul 29, 2026
- FDA UDI a75bf45d-2ed6-4b6d-940a-e7933f456ab5 34 fields · synced May 30, 2026