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Ice-berg∙oss™ Block
EUDAMEDClass III (EU MDR)
Ref IOB8825Ref IOB8812Ref IOB6625Ref IOB6612
Identity
- Trade Name
- Ice-berg∙oss™ Block EUDAMED
- Device Name
- Ice-berg∙oss™ Block EUDAMED
- Model / Reference
- IOB8825 EUDAMEDIOB8812 EUDAMEDIOB6625 EUDAMEDIOB6612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490620543 EUDAMED08809490620536 EUDAMED08809490620482 EUDAMED08809490620475 EUDAMED
- Basic UDI-DI
- B-08809490620543 EUDAMEDB-08809490620536 EUDAMEDB-08809490620482 EUDAMEDB-08809490620475 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ice-berg∙oss™ Block by Chiyewon Co., LTD. — Class III — 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-08809490620543 | Class III | Active |
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Manufacturer
- Manufacturer
- Chiyewon Co., LTD.
- EUDAMED SRN
- KR-MF-000022264
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED b9ca5a60-6c3a-42d7-ac5e-3379c5572257 61 fields · synced Aug 4, 2026
- EUDAMED 6251b6cd-38c7-4d2b-b429-df7adc0f5277 61 fields · synced May 17, 2026
- EUDAMED 40f93436-c8c7-4d5b-a769-9fee896b1cbb 61 fields · synced May 18, 2026
- EUDAMED 6460cb96-b472-4631-984f-bcf4253e3bb4 61 fields · synced May 19, 2026