Identity
- Trade Name
- ScanBody EUDAMED
- Device Name
- IH IMPLANT SYSTEM / Laboratory components & Etc. EUDAMED
- Model / Reference
- IHTBRSB EUDAMEDIH2FMSB EUDAMEDIHTBMSB EUDAMEDIH2FRSB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041364435 EUDAMED08800041364398 EUDAMED08800041364428 EUDAMED08800041364411 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
ScanBody 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 (4)
- EUDAMED eddc9bf2-5b02-4770-b3ea-ef666ca9cb43 61 fields · synced Jul 21, 2026
- EUDAMED 2cc50a52-b7c5-4fa6-9c2f-c86d9007d4be 61 fields · synced May 17, 2026
- EUDAMED 221daaa6-e055-4b60-9f31-99680d7114a9 61 fields · synced May 17, 2026
- EUDAMED 6a1fb673-5239-4fad-8777-f9bf6b7d48e5 61 fields · synced May 18, 2026