Identity
- Trade Name
- Dental unit EUDAMED
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- AL-398AA EUDAMEDAL-398HB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975313510079 EUDAMED
- Basic UDI-DI
- 697531351AL0018X EUDAMED
- Direct Marketing DI
- 06975313510079 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dental unit by Foshan Anle Medical Apparatus Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697531351AL0018X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Anle Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000023847
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 098490c3-fbcd-4271-ae82-f0acb1cedb79 61 fields · synced Jun 17, 2026