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Expander Drill
EUDAMEDClass IIa (EU MDR)
Ref SEP223610Model IH IMPLANT SYSTEM Ref SEP314508Ref SEP314511Ref SEP274111Ref SEP274110Ref SEP274108
Identity
- Trade Name
- Expander Drill EUDAMED
- Device Name
- Expander Drill EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSEP223610 EUDAMEDSEP314508 EUDAMEDSEP314511 EUDAMEDSEP274111 EUDAMEDSEP274110 EUDAMEDSEP274108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041364626 EUDAMED08800041364671 EUDAMED08800041364695 EUDAMED08800041364664 EUDAMED08800041364657 EUDAMED08800041364640 EUDAMED
- Basic UDI-DI
- B-08800041364626 EUDAMEDB-08800041364671 EUDAMEDB-08800041364695 EUDAMEDB-08800041364664 EUDAMEDB-08800041364657 EUDAMEDB-08800041364640 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
Expander Drill 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-08800041364626 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (6)
- EUDAMED 465e5feb-6412-43e3-985f-20592542f99a 61 fields · synced Aug 2, 2026
- EUDAMED 6c790799-7f95-4528-8ea4-128a87535517 61 fields · synced May 17, 2026
- EUDAMED ae6213e9-fe10-4de1-9d69-871cc5e178aa 61 fields · synced May 17, 2026
- EUDAMED b89b75bd-9963-40a6-a6c6-df1d7c8d9ee4 61 fields · synced May 18, 2026
- EUDAMED c6acaeb8-9186-43db-ad2f-d7fa4f32f404 61 fields · synced May 19, 2026
- EUDAMED b87055e1-aac8-4695-9e41-aab1f0d18e97 61 fields · synced May 19, 2026