Surgical Kit-K5
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Surgical Kit-K5 EUDAMEDSurgical Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Surgical Kit-K5 EUDAMEDSEWON MEDIX Surgical KIT SEK5B FDA UDI
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSEK5B EUDAMEDFDA UDI
- Description
- SEWON MEDIX Surgical KIT SEK5B FDA UDI
Identifiers
- Catalog Number
- SEK5B FDA UDI
- Primary DI / UDI-DI
- 08800041359653 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800041359653 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Surgical Kit-K5 by SEWONMEDIX Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800041359653 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 8d989103-8885-4a7a-82a0-e3caafe8a6d8 61 fields · synced Jun 19, 2026
- FDA UDI c1ac83f4-c533-4f25-ba86-2b588251cc12 34 fields · synced May 30, 2026