ISO 13485:2016
Scope: Manufacturing and Sales of Electrosurgical Units and Medical Light Source Equipment.
Registration No.: IC-MD-2508059
Quality & Certifications
Documented Quality Systems for Medical-Device Manufacturing
APRUS Technologies maintains certified management systems covering medical-device quality, general quality management, environmental management, and occupational health & safety. Product compliance documentation is presented according to the scope and dates stated on the respective certificates.
Management Systems
Certified quality and operational frameworks.
ISO 13485:2016Medical Devices Quality Management System
ISO 9001:2015Quality Management System
ISO 14001:2015Environmental Management System
ISO 45001:2018Occupational Health & Safety Management System
ISO 9001:2015
Scope: Manufacturing and Sales of Medical Equipment.
Registration No.: IC-QM-2508056
ISO 14001:2015
Scope: Manufacturing and Sales of Medical Equipment.
Registration No.: IC-EM-2508057
ISO 45001:2018
Scope: Manufacturing and Sales of Medical Equipment.
Registration No.: IC-OS-2508058
Product Compliance
Certificate of Compliance — High Frequency Electrosurgical Generator
The current Certificate of Compliance covers APRUS High Frequency Electrosurgical Generators and specifically identifies the Alpha 1.0-IR, Alpha 1.0-IRSL and Alpha Smart models.
Certificate NumberTCE/PK363/04642207
ProductHigh Frequency Electrosurgical Generator
ModelsAlpha 1.0-IR, Alpha 1.0-IRSL, Alpha Smart
Applicable Directive / Annex93/42/EEC — Annex II, excluding Section 4
Product ClassificationClass IIb
Initial Certification Date16 July 2025
Issue Date22 July 2026
Expiry Date21 July 2027
Revision00
Standards Referenced on the Certificate
ISO 14971
EN 60601-1
EN 60601-1-1
EN 60601-1-2
EN 60601-2-2
APRUS presents this document according to the scope, wording, dates and conditions stated on the certificate itself. For procurement, regulatory or distributor evaluation, the current certificate image and supporting documentation can be requested directly from APRUS Technologies.
Quality Approach
Quality integrated into the manufacturing process.
APRUS's quality framework supports structured design, manufacturing, sales and organizational processes relevant to its medical-device activities. The company's ISO 13485 certification specifically covers manufacturing and sales of electrosurgical units and medical light source equipment.
Additional management-system certifications support broader quality, environmental and occupational health & safety practices across the organization.
For Procurement & Distribution
Need current documents?
Hospitals, procurement departments, distributors and prospective partners can request current quality and product-compliance documentation directly from APRUS.
Request DocumentationAPRUS Technologies
Quality credentials backed by documented scope.
Review APRUS products, discuss procurement requirements or contact the company for current certification documents.