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Sidecut Drill
EUDAMEDClass IIa (EU MDR)
Ref IHSCDS30LModel IH IMPLANT SYSTEM Ref IHSCD30LRef IHSCDS20SRef IHSCD20SRef IHSCD25SRef IHSCD20L
Identity
- Trade Name
- Sidecut Drill EUDAMED
- Device Name
- Sidecut Drill EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHSCDS30L EUDAMEDIHSCD30L EUDAMEDIHSCDS20S EUDAMEDIHSCD20S EUDAMEDIHSCD25S EUDAMEDIHSCD20L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041367443 EUDAMED08800041361700 EUDAMED08800041367405 EUDAMED08800041361656 EUDAMED08800041361670 EUDAMED08800041361663 EUDAMED
- Basic UDI-DI
- B-08800041367443 EUDAMEDB-08800041361700 EUDAMEDB-08800041367405 EUDAMEDB-08800041361656 EUDAMEDB-08800041361670 EUDAMEDB-08800041361663 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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Sidecut Drill by SEWONMEDIX Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800041367443 | 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 0051ca0a-c2ce-4b1a-90c2-1c01bd7850ed 61 fields · synced Aug 4, 2026
- EUDAMED 81bc278d-a2ff-4b43-8b7c-8b2db3122b69 61 fields · synced May 17, 2026
- EUDAMED f5b2b667-1c3e-479e-8d26-95514f00b003 61 fields · synced May 17, 2026
- EUDAMED f3682f1d-b193-4a07-8697-debc7ca52c5a 61 fields · synced May 18, 2026
- EUDAMED 330e05ed-5467-4eb3-a79d-0cc863bc804e 61 fields · synced May 18, 2026
- EUDAMED a43b9853-4ca2-4baf-8311-81a5ac177de8 61 fields · synced May 18, 2026