Eu Mdd
Eu Md Class 2a
On The Market
🇰🇷 South Korea
Maxillary Skeletal Expander
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08800099060907
- Basic UDI-DI Code
- B-08800099060907
- Reference
- RPE-8-001
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- BioMaterials Korea, Inc.
Additional Description
MSE (Maxillary Skeletal Expander) is indicated in miniscrew-assisted RPE (MARPE) for correction of maxillary transverse deficiencies in skeletally mature patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q01020604 | ORTHODONTIC DENTAL PROSTHESES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | M.2016.106.7388 | UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. | Expired |
Available In Countries
🇪🇸 Spain
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