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Surgical Kit
EUDAMEDClass IIa (EU MDR)
Ref SFK-X01Model IH IMPLANT SYSTEM Ref SEK5BPRef SPK5BRef SEK5BTWRef STK5SRef SPK5SRef STK5BTRef SEK5S
Identity
- Trade Name
- Surgical Kit EUDAMEDSurgical Kit-K5 EUDAMED
- Device Name
- Surgical Kit EUDAMEDSurgical Kit-K5 EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSFK-X01 EUDAMEDSEK5BP EUDAMEDSPK5B EUDAMEDSEK5BTW EUDAMEDSTK5S EUDAMEDSPK5S EUDAMEDSTK5BT EUDAMEDSEK5S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041359790 EUDAMED08800041366170 EUDAMED08800041359707 EUDAMED08800041359677 EUDAMED08800041359646 EUDAMED08800041359714 EUDAMED08800041359639 EUDAMED08800041359691 EUDAMED
- Basic UDI-DI
- B-08800041359790 EUDAMEDB-08800041366170 EUDAMEDB-08800041359707 EUDAMEDB-08800041359677 EUDAMEDB-08800041359646 EUDAMEDB-08800041359714 EUDAMEDB-08800041359639 EUDAMEDB-08800041359691 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
Surgical Kit 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-08800041359790 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (8)
- EUDAMED 18b3a7be-ffd4-46fb-b73f-fff53bf943ee 61 fields · synced Aug 3, 2026
- EUDAMED 460f857f-293d-40c5-8958-da73c41b0aea 61 fields · synced May 16, 2026
- EUDAMED f5648462-89ec-4eab-819b-e80aa4837e61 61 fields · synced May 17, 2026
- EUDAMED f3bcf5f4-465c-48c4-b485-681d234427a9 61 fields · synced May 17, 2026
- EUDAMED 28444ad8-e8b2-4b39-8c97-12d2ea3cc336 61 fields · synced May 17, 2026
- EUDAMED fce763f7-f148-40fa-a275-df6b44892e6c 61 fields · synced May 18, 2026
- EUDAMED 0ba0b5c6-cb96-418b-89ac-acaee36cc08b 61 fields · synced May 18, 2026
- EUDAMED fd41ed12-9e2c-4870-ba32-f53180de1a26 61 fields · synced May 18, 2026