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Surgical Kit-K7
EUDAMEDClass IIa (EU MDR)
Ref SPK7BModel IH IMPLANT SYSTEM Ref SEK7BPRef SPK7S
Identity
- Trade Name
- Surgical Kit-K7 EUDAMED
- Device Name
- Surgical Kit-K7 EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSPK7B EUDAMEDSEK7BP EUDAMEDSPK7S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041359776 EUDAMED08800041359752 EUDAMED08800041359783 EUDAMED
- Basic UDI-DI
- B-08800041359776 EUDAMEDB-08800041359752 EUDAMEDB-08800041359783 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-K7 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-08800041359776 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 6a661d3b-068e-472c-8eed-4bf8dac3c617 61 fields · synced Aug 2, 2026
- EUDAMED b192cdd6-7b92-4408-98cd-9e6b6dad1624 61 fields · synced May 16, 2026
- EUDAMED 0153b1a1-0d1d-4861-ab80-589abe9075aa 61 fields · synced May 19, 2026