Identity
- Trade Name
- CROWN PX EUDAMED
- Model / Reference
- 20PCS,S41S,UL1,D3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- PUCPXS41SL1XD3 EUDAMED
- Basic UDI-DI
- B-PUCPXS41SL1XD3 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
Crown Px by Yamahachi Dental Mfg., Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Partial denture.
- NEW ACE/MILLION COMBINATION SET — YAMAHACHI DENTAL MFG., CO. · Class IIa
- NEW ACE/NAPERCE 4 PLATE SAMPLE — YAMAHACHI DENTAL MFG., CO. · Class IIa
- EFUCERA-A — YAMAHACHI DENTAL MFG., CO. · Class IIa
- FX ANTERIOR — YAMAHACHI DENTAL MFG., CO. · Class IIa
- FX ANTERIOR/EFUCERA FX COMBINATION SET — YAMAHACHI DENTAL MFG., CO. · Class IIa
- NEW ACE — YAMAHACHI DENTAL MFG., CO. · Class IIa
- SOLUUT PX/EFUCERA PX COMBINATION SET — YAMAHACHI DENTAL MFG., CO. · Class IIa
- NEW ACE/NAPERCE FULL SET — YAMAHACHI DENTAL MFG., CO. · Class IIa
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-PUCPXS41SL1XD3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yamahachi Dental Mfg., Co.
- EUDAMED SRN
- JP-MF-000024849
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED bb50b0e8-d0d8-435d-8759-fa91d406884d 61 fields · synced May 23, 2026