Efucera Px
by Yamahachi Dental Mfg., Co. 1,000+ variants
Ref 20PCS,28,LL5,B4
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The EFUCERA PX medical device is a Class IIa instrument used for measuring endocrine disruptors. It features a self-testing capability, but no reagent or sterilization needs to be replaced. The device has undergone professional testing and is applicable for clinical use in certain jurisdictions. Its version number indicates an update to the previous model.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-PLEPXXX28L5XB4 PLEPXXX28L5XB4 | Date25 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- 20PCS, 28, LL5, B4
- Primary DI / UDI-DI
- PLEPXXX28L5XB4
- Basic UDI-DI
- B-PLEPXXX28L5XB4
- EMDN Code
- Q01020601 Mobile dental prostheses
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000024849
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Yamahachi Dental Mfg., Co.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No