Eu Mdd
Eu Md Class 2b
On The Market
🇹🇼 Taiwan
Protable X-Ray XR-01
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 04713909450628
- Basic UDI-DI Code
- B-04713909450628
- Reference
- 1500
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Rolence Enterprise Inc.
Additional Description
The Portable X-Ray system is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039016 | MOBILE RADIOGRAPHIC UNITS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-136/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇹🇷 Türkiye
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