OPTIMA-R™ Cemented Femoral Stem

by Tianjin Zhengtian Medical Instrument Co., Ltd. China EUDAMED

Ref C25710127 EMDN P090804010101

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06921814268544 Basic UDI-DI	Date14 Sep 2024Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: OPTIMA-R™ Cemented Femoral Stem
Model / Reference: C25710127

Primary DI / UDI-DI: 06921814268544
Basic UDI-DI: B-06921814268544
EMDN Code: P090804010101 Cemented femoral stems for primary implant, with fixed neck, straight

Device Class: Class III
Market of Registration: Portugal

Manufacturer details

EUDAMED SRN: CN-MF-000020115
Authorised representative: Inion Oy FI-AR-000046224

Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.

2.4/2.7mm Distal Radius Volar Column Locking Plate

Class IIb
2.4/2.7mm LCP Distal Radius T Plate

Class IIb
2.4/2.7mm Distal Radius Extra-articular Volar Locking T-Plate

Class IIb
2.4/2.7mm VA Distal Radius Two-Column Volar Locking Plate, Broad

Class IIb
3.5mm LCP Limited Contact Humerus Plate

Class IIb
Lateral Tibial Head Buttress Plate

Class IIb

See all devices from Tianjin Zhengtian Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Sterile
Implantable

Other properties (9)

Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (1)

EUDAMED 799a6ed7-03d4-4dea-80e0-23af1bab6161 61 fields · synced 22 Oct 2026