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New Ace/Naperce Combination Set

EUDAMED

Class IIa (EU MDR)

Ref 28*1SET,O3L3M30,UL,A3.5

by Yamahachi Dental Mfg., Co.

Identity

Trade Name
NEW ACE/NAPERCE COMBINATION SET EUDAMED
Model / Reference
28*1SET,O3L3M30,UL,A3.5 EUDAMED

Identifiers

Primary DI / UDI-DI
CSNNAZZ42ULA35 EUDAMED
Basic UDI-DI
B-CSNNAZZ42ULA35 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/Naperce Combination Set by Yamahachi Dental Mfg., Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Partial denture.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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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 4ee595e3-08e2-4cff-b6f8-312212288eba 61 fields · synced Jun 18, 2026
  • EUDAMED 4ee595e3-08e2-4cff-b6f8-312212288eba-1 61 fields · synced Jun 10, 2026