Identity
- Trade Name
- NEW ACE/MILLION FULL SET EUDAMED
- Model / Reference
- 28*1SET,TL4L631,UL,A4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- FSNMIZ287ULXA4 EUDAMED
- Basic UDI-DI
- B-FSNMIZ287ULXA4 EUDAMED
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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: Partial denture
New Ace/Million Full Set by Yamahachi Dental Mfg., Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Partial denture.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-FSNMIZ287ULXA4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
- EUDAMED SRN
- JP-MF-000024849
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d3a9ab04-6f22-4b85-bf9b-a0996b7843f0 61 fields · synced Jul 17, 2026
- EUDAMED d3a9ab04-6f22-4b85-bf9b-a0996b7843f0-1 61 fields · synced Jun 9, 2026