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IH2 SLA Fixture
EUDAMEDClass IIb (EU MDR)
Ref IH2FR4510SModel IH IMPLANT SYSTEM
Identity
- Trade Name
- IH2 SLA Fixture EUDAMED
- Device Name
- IH2 SLA Fixture EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIH2FR4510S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041300204 EUDAMED
- Basic UDI-DI
- B-08800041300204 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IH2 SLA Fixture 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-08800041300204 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED becbabd5-7f4b-47ff-bb28-9c6131022088 61 fields · synced May 22, 2026