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Screw Driver for Machine
EUDAMEDClass IIa (EU MDR)
Ref MHD123LModel IH IMPLANT SYSTEM
Identity
- Trade Name
- Screw Driver for Machine EUDAMED
- Device Name
- Screw Driver for Machine EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDMHD123L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041362257 EUDAMED
- Basic UDI-DI
- B-08800041362257 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
Screw 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-08800041362257 | 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 efbeb8a5-0360-4005-9c9b-b3857cc6ed84 61 fields · synced Jun 19, 2026