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Prosthetics Kit
EUDAMEDClass IIa (EU MDR)
Ref PK120BSModel IH IMPLANT SYSTEM Ref PK123SSRef PK120SSRef PK128SRef PK125SSRef PK125BSRef PK5S
Identity
- Trade Name
- Prosthetics Kit EUDAMED
- Device Name
- Prosthetics Kit EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDPK120BS EUDAMEDPK123SS EUDAMEDPK120SS EUDAMEDPK128S EUDAMEDPK125SS EUDAMEDPK125BS EUDAMEDPK5S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041359851 EUDAMED08800041359882 EUDAMED08800041359844 EUDAMED08800041359943 EUDAMED08800041359929 EUDAMED08800041359936 EUDAMED08800041359981 EUDAMED
- Basic UDI-DI
- B-08800041359851 EUDAMEDB-08800041359882 EUDAMEDB-08800041359844 EUDAMEDB-08800041359943 EUDAMEDB-08800041359929 EUDAMEDB-08800041359936 EUDAMEDB-08800041359981 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
Prosthetics Kit by SEWONMEDIX Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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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-08800041359851 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (7)
- EUDAMED fe66aa88-562e-4e3f-a23c-dba0b2bd3c41 61 fields · synced Jul 27, 2026
- EUDAMED 73960833-2481-4292-b410-7156f669bc41 61 fields · synced May 18, 2026
- EUDAMED 7b6db01b-2b22-4745-9e96-e5a3475745dd 61 fields · synced May 18, 2026
- EUDAMED dc28d881-fb56-4349-bb34-538a4513729c 61 fields · synced May 18, 2026
- EUDAMED efd51a0d-0b96-4052-b922-9538dd286877 61 fields · synced May 18, 2026
- EUDAMED 30f98656-989e-4f4f-a8f2-cd2b7b1b8064 61 fields · synced May 18, 2026
- EUDAMED 4c1d01a3-863b-4d33-bc72-ba68776c06a5 61 fields · synced May 18, 2026