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Tissue Punch
EUDAMEDClass IIa (EU MDR)
Ref STP38BModel IH IMPLANT SYSTEM Ref STP33Ref STP33BRef STP43BRef STP48Ref STP43
Identity
- Trade Name
- Tissue Punch EUDAMED
- Device Name
- Tissue Punch EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDSTP38B EUDAMEDSTP33 EUDAMEDSTP33B EUDAMEDSTP43B EUDAMEDSTP48 EUDAMEDSTP43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041361861 EUDAMED08800041361915 EUDAMED08800041361854 EUDAMED08800041361878 EUDAMED08800041361946 EUDAMED08800041361939 EUDAMED
- Basic UDI-DI
- B-08800041361861 EUDAMEDB-08800041361915 EUDAMEDB-08800041361854 EUDAMEDB-08800041361878 EUDAMEDB-08800041361946 EUDAMEDB-08800041361939 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
Tissue Punch 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-08800041361861 | 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 1fd048dc-4b99-4a93-9e20-7899ec4826e1 61 fields · synced Jul 26, 2026
- EUDAMED 54a3adc6-5d2e-49d6-b04d-43d28f80cd9c 61 fields · synced May 17, 2026
- EUDAMED 760b8780-cc78-4253-b0e8-7a00cdbdf7cf 61 fields · synced May 18, 2026
- EUDAMED 59e94e11-895e-4b9f-957c-3b9975f07867 61 fields · synced May 18, 2026
- EUDAMED 4b4e1c88-7631-4632-94b4-017c66fa1e01 61 fields · synced May 18, 2026
- EUDAMED d18963f6-7bb2-4b08-ba52-6f8e60c32324 61 fields · synced May 18, 2026