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Tissue Punch Guide Pin
EUDAMEDClass IIa (EU MDR)
Ref TGP43Model IH IMPLANT SYSTEM Ref TGP48Ref TGP63Ref TGP53Ref TGP33
Identity
- Trade Name
- Tissue Punch Guide Pin EUDAMED
- Device Name
- Tissue Punch Guide Pin EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDTGP43 EUDAMEDTGP48 EUDAMEDTGP63 EUDAMEDTGP53 EUDAMEDTGP33 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041361991 EUDAMED08800041362004 EUDAMED08800041362028 EUDAMED08800041362011 EUDAMED08800041361977 EUDAMED
- Basic UDI-DI
- B-08800041361991 EUDAMEDB-08800041362004 EUDAMEDB-08800041362028 EUDAMEDB-08800041362011 EUDAMEDB-08800041361977 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 Guide Pin 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-08800041361991 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (5)
- EUDAMED 1b5e65e7-8285-49d4-bcc1-35ad8217c0f2 61 fields · synced Aug 4, 2026
- EUDAMED 3a2b49bd-3e02-4fd9-8fe8-f9d14d88969e 61 fields · synced May 17, 2026
- EUDAMED 7a96d833-3691-4266-8256-6187e2017561 61 fields · synced May 17, 2026
- EUDAMED 2cac8f8c-82e5-4ecd-a4b9-4d1da4f5a860 61 fields · synced May 19, 2026
- EUDAMED 9e1d42c1-8442-4720-8363-e5e6cb7fbc49 61 fields · synced May 19, 2026