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Dental unit
EUDAMEDClass IIa (EU MDR)
Ref AL-398HAModel AL-398AARef AL-388S3Ref AL-388S2Ref AL-388SDRef AL-388S1Ref AL-388SBRef AL-398HCRef AL-388SARef AL-398HF
Identity
- Trade Name
- Dental unit EUDAMED
- Device Name
- Dental Unit EUDAMED
- Model / Reference
- AL-398AA EUDAMEDAL-398HA EUDAMEDAL-388S3 EUDAMEDAL-388S2 EUDAMEDAL-388SD EUDAMEDAL-388S1 EUDAMEDAL-388SB EUDAMEDAL-398HC EUDAMEDAL-388SA EUDAMEDAL-398HF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975313510130 EUDAMED06975313510109 EUDAMED06975313510093 EUDAMED06975313510055 EUDAMED06975313510086 EUDAMED06975313510154 EUDAMED06975313510024 EUDAMED06975313510147 EUDAMED06975313510048 EUDAMED06975313510000 EUDAMED
- Basic UDI-DI
- 697531351AL0018X EUDAMED
- Direct Marketing DI
- 06975313510130 EUDAMED06975313510109 EUDAMED06975313510093 EUDAMED06975313510055 EUDAMED06975313510086 EUDAMED06975313510154 EUDAMED06975313510024 EUDAMED06975313510147 EUDAMED06975313510048 EUDAMED06975313510000 EUDAMED
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDRomania 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 (10)
- EUDAMED b5809dd7-347b-42a4-ac00-eaddab0a578b 61 fields · synced Aug 3, 2026
- EUDAMED 447b63d0-5163-4df5-a4ef-f4be7b1e69a2 61 fields · synced May 17, 2026
- EUDAMED bfdae660-5728-4930-8c69-edae3a236375 61 fields · synced May 17, 2026
- EUDAMED 2f2829d1-1d1f-4ac3-be98-6d51f9645e12 61 fields · synced May 17, 2026
- EUDAMED 3d54e654-719c-4aea-bdb2-5b333226532b 61 fields · synced May 17, 2026
- EUDAMED 65520b59-6ba7-4a50-931f-d9ef7f1ccff9 61 fields · synced May 18, 2026
- EUDAMED e3964856-4277-498e-a3be-218c63e4b350 61 fields · synced May 18, 2026
- EUDAMED ba1b6ce3-0657-4f47-b194-92964b5e628a 61 fields · synced May 18, 2026
- EUDAMED 1767153c-8c34-4bfc-894c-e2e69da5a9af 61 fields · synced May 18, 2026
- EUDAMED 561c5478-43d0-48c5-b730-1c30e8643a46 61 fields · synced May 18, 2026