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Surgical Tap
EUDAMEDClass IIa (EU MDR)
Ref IHFTM37Model IH IMPLANT SYSTEM Ref IHFTM45Ref IHFTM40Ref IHFTR45Ref IHFTM50Ref IHFTM60Ref IHFTR40
Identity
- Trade Name
- Surgical Tap EUDAMED
- Device Name
- Surgical Tap EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHFTM37 EUDAMEDIHFTM45 EUDAMEDIHFTM40 EUDAMEDIHFTR45 EUDAMEDIHFTM50 EUDAMEDIHFTM60 EUDAMEDIHFTR40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041362042 EUDAMED08800041362066 EUDAMED08800041362059 EUDAMED08800041362127 EUDAMED08800041362073 EUDAMED08800041362080 EUDAMED08800041362110 EUDAMED
- Basic UDI-DI
- B-08800041362042 EUDAMEDB-08800041362066 EUDAMEDB-08800041362059 EUDAMEDB-08800041362127 EUDAMEDB-08800041362073 EUDAMEDB-08800041362080 EUDAMEDB-08800041362110 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
Surgical Tap 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-08800041362042 | 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 207ba75a-5b3f-48da-91c1-068b7fa55db9 61 fields · synced Jul 22, 2026
- EUDAMED 71c50be9-95f6-4f2d-a5aa-ea62315fc2e7 61 fields · synced May 17, 2026
- EUDAMED cf960d35-37bd-4d2b-97bc-b16ce8054a7c 61 fields · synced May 17, 2026
- EUDAMED 28b40c75-fc1a-4f5a-9d47-b596bae89816 61 fields · synced May 18, 2026
- EUDAMED eafd180c-50c9-4ef4-9547-ee6bb5137db4 61 fields · synced May 18, 2026
- EUDAMED 967987eb-62bd-44c4-ae7d-8bd70e603b36 61 fields · synced May 18, 2026
- EUDAMED b70e6ba9-fda7-43fa-b51f-6d923f29f22a 61 fields · synced May 19, 2026