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Mount Driver for Machine
EUDAMEDClass IIa (EU MDR)
Ref FMDMLModel IH IMPLANT SYSTEM
Identity
- Trade Name
- Mount Driver for Machine EUDAMED
- Device Name
- Mount Driver for Machine EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDFMDML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041363292 EUDAMED
- Basic UDI-DI
- B-08800041363292 EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mount Driver for Machine by SEWONMEDIX Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800041363292 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 72fa7cd9-4f52-461e-b96e-86487e9b8a70 61 fields · synced May 22, 2026