Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
Basic Information
- Primary DI
- 08809490620345
- Basic UDI-DI Code
- B-08809490620345
- Reference
- IO201217
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Chiyewon Co., LTD.
Additional Description
Device is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Device is packaged and sterilized using gamma irradiation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q010302 | DENTAL GRAFT DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-275/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| MDD Annex II Section 4 | 1434-MDD-274/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇪🇸 Spain
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