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IH Cover Screw
EUDAMEDClass IIb (EU MDR)
Ref IHCSR32Model IH IMPLANT SYSTEM Ref IHCSR
Identity
- Trade Name
- IH Cover Screw EUDAMED
- Device Name
- IH Cover Screw EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDIHCSR32 EUDAMEDIHCSR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041302178 EUDAMED08800041302161 EUDAMED
- Basic UDI-DI
- B-08800041302178 EUDAMEDB-08800041302161 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
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IH Cover Screw 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-08800041302178 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 11abb8ea-1148-4912-afc6-1ab6e1aebbd3 61 fields · synced Jul 10, 2026
- EUDAMED ffb7c06c-b165-48ce-88e5-565d03d8f7ce 61 fields · synced May 17, 2026