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Ti-Custom Block
EUDAMEDClass IIb (EU MDR)
Ref AOTRTB10Model IH IMPLANT SYSTEM Ref AIHCBRH14Ref AOTMTB10Ref AIHCBMH10Ref AIHCBRN10Ref AIHCBRH14DRef AIHCBRH10DRef AIHCBMN10
Identity
- Trade Name
- Ti-Custom Block EUDAMED
- Device Name
- Ti-Custom Block EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAOTRTB10 EUDAMEDAIHCBRH14 EUDAMEDAOTMTB10 EUDAMEDAIHCBMH10 EUDAMEDAIHCBRN10 EUDAMEDAIHCBRH14D EUDAMEDAIHCBRH10D EUDAMEDAIHCBMN10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041358762 EUDAMED08800041358670 EUDAMED08800041358748 EUDAMED08800041358649 EUDAMED08800041358700 EUDAMED08800041358731 EUDAMED08800041358724 EUDAMED08800041358687 EUDAMED
- Basic UDI-DI
- B-08800041358762 EUDAMEDB-08800041358670 EUDAMEDB-08800041358748 EUDAMEDB-08800041358649 EUDAMEDB-08800041358700 EUDAMEDB-08800041358731 EUDAMEDB-08800041358724 EUDAMEDB-08800041358687 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ti-Custom Block by SEWONMEDIX Inc. — Class IIb — 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-08800041358762 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (8)
- EUDAMED a357ad30-2d0f-4865-8d07-b283c6fce46e 61 fields · synced Sep 18, 2026
- EUDAMED d38b3732-3ecd-4e1e-a2a6-0bda1e3b01cc 61 fields · synced May 17, 2026
- EUDAMED 71ec67ce-6e1f-4a0e-8db9-4b9c47f932a1 61 fields · synced May 17, 2026
- EUDAMED cb33bdb3-8100-4d17-b4cf-3691d8a8663a 61 fields · synced May 18, 2026
- EUDAMED 96822e3e-76b8-4440-b61e-50f0436954f8 61 fields · synced May 18, 2026
- EUDAMED afacecc9-0fd8-4391-b10a-f4ec00f9e616 61 fields · synced May 18, 2026
- EUDAMED 2cd1f309-f866-4409-a4d7-6fec11634a75 61 fields · synced May 19, 2026
- EUDAMED c41a744b-759a-4b23-a71e-6f2e6df6d292 61 fields · synced May 19, 2026