Identity
- Trade Name
- Dental unit EUDAMED
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- AL-398AA EUDAMEDAL-398BB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975313510161 EUDAMED
- Basic UDI-DI
- 697531351AL0018X EUDAMED
- Direct Marketing DI
- 06975313510161 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
Category: Dental delivery system
Dental unit by Foshan Anle Medical Apparatus Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 76834295-ada1-4e8d-9b85-60d4a05b2e4e 61 fields · synced Jun 19, 2026