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CompactBone® B+
EUDAMEDClass III (EU MDR)
Ref BOV06SModel BOV06SRef BOV15LRef BOV48SRef BOV08LRef BOV30LRef BOV12SRef BOV60LRef BOV04PRef BOV30P
Identity
- Trade Name
- CompactBone® B+ EUDAMED
- Device Name
- CompactBone® B+ EUDAMED
- Model / Reference
- BOV06S EUDAMEDBOV15L EUDAMEDBOV48S EUDAMEDBOV08L EUDAMEDBOV30L EUDAMEDBOV12S EUDAMEDBOV60L EUDAMEDBOV04P EUDAMEDBOV30P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809490623292 EUDAMED08809490623346 EUDAMED08809490623322 EUDAMED08809490623339 EUDAMED08809490623353 EUDAMED08809490623308 EUDAMED08809490623360 EUDAMED08809490623254 EUDAMED08809490623285 EUDAMED
- Basic UDI-DI
- B-08809490623292 EUDAMEDB-08809490623346 EUDAMEDB-08809490623322 EUDAMEDB-08809490623339 EUDAMEDB-08809490623353 EUDAMEDB-08809490623308 EUDAMEDB-08809490623360 EUDAMEDB-08809490623254 EUDAMEDB-08809490623285 EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
CompactBone® B+ 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-08809490623292 | 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 (9)
- EUDAMED e638e330-b838-4cf8-9b62-b953a0c5baa3 61 fields · synced Aug 1, 2026
- EUDAMED 674a2c8b-a797-40e5-bf5e-b48f260a4e51 61 fields · synced May 17, 2026
- EUDAMED 51af13b1-29f0-42e6-a3bb-0283bb34048f 61 fields · synced May 18, 2026
- EUDAMED d371934c-1f4e-40d3-b615-d936075dd2fd 61 fields · synced May 18, 2026
- EUDAMED 3a0f319f-b759-483f-9fa7-58593016e503 61 fields · synced May 18, 2026
- EUDAMED 63d44221-e0d8-40e4-b0be-f956eaa9f8b3 61 fields · synced May 18, 2026
- EUDAMED a5a50de8-a695-4e77-87bd-12441f312c21 61 fields · synced May 18, 2026
- EUDAMED 0cba8ac5-ef27-408c-8cc7-39faae177656 61 fields · synced May 19, 2026
- EUDAMED c55fa2f1-18a3-4164-aa55-fee99959ce17 61 fields · synced May 19, 2026