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IH CCM Casting Abutment
EUDAMEDClass IIb (EU MDR)
Ref AIHCCARH4510Model IH IMPLANT SYSTEM
Identity
- Trade Name
- IH CCM Casting Abutment EUDAMED
- Device Name
- IH CCM Casting Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHCCARH4510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041358489 EUDAMED
- Basic UDI-DI
- B-08800041358489 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 CCM Casting Abutment 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-08800041358489 | 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 e3665f1a-1f86-4e3a-8bc3-bfb7170b87b5 61 fields · synced Jun 18, 2026