Ensemble d'instruments de diagnostic ORL Lapa Master Industry, classe I, certifié CE, ISO13485, utilisation médicale et chirurgicale manuelle

1 AN

Support technique en ligne

Pakistan

Classe JE

Lapa Master Industry

LMI-733069-52-1

manuel

ORL, Réutilisable, Ent chirurgical, Médical hôpital, Ent médical, Formation de suture étudiants en médecine

1 ans

Ce

Ensemble d'instrument

ISO 9001, ISO 13485, ISO 7376, ISO 50001, ISO 14971, ISO 10993-1, ISO 7153-1, EN 10088-1, CE Certificate, GMP Certificate, Free Sale Certificate, Representative (EC REP EUDAMED), Technical Support Documents & Compliance

30*25*5 Boxboard Boxes Carton 50*31*27 cm

LMI Brand 20 Set Packed Boxboard Boxes in 1 Carton, Certifications for Laryngoscope Premium Quality. 01. ISO 9001:2015-IAF 02. ISO 13485:2016-IAF 03. ISO 7376:2020 04. ISO 50001:2015 05. ISO 14971:2019 06. ISO 14971:2015 07. ISO 10993-1:2018 08. ISO 7153-1: 09. EN 10088-1 10. CE Certificate 11. GMP Certificate 12. Free Sale Certificate. 13. Representative (EC REP EUDAMED) 14. Technical Support Documents & Compliance Certifications, Biocompatibility Tests 1. Cytotoxicity Test (ISO 10993-5): Evaluates the Potential of the Device to cause cellular Damage. 2. Skin Sensitization Study (ISO 10993-10): Assesses the Device's Potential to cause allergic reactions. 3. Acute Irritation & Intracutaneous Reactivity in Rabbit (ISO 10993-10): Evaluates the Device's potential to cause Skin irritation. 4. Material-Mediated Pyrogenicity (ISO 10993-11): Assesses the device's potential to cause fever. 5. Systemic Toxicity (Acute) ISO 10993-11: Evaluates the Device's potential to cause systemic toxicity. 6. Hemocompatibility (ISO 10993-14): Assesses the Device's Potential to cause Adverse Reactions with Blood., ENT Diagnostic Set Set for Premium Quality LMI Brand 20 Set Packed Boxboard Boxes in 1 Carton- 100 Sets LMI Brand 20 Set Packed Boxes in 5 Cartons, Teachnical Files Documents 01 - Biocompatibility Report for ENT Diagnostic Set 02 - Certificate of Analysis for ENT Diagnostic Set 03 - Clinical Study & Biofunctionality Report for ENT Diagnostic Set 04 - Corrosion Test Report for ENT Diagnostic Set 05 - Declaration of Conformity for ENT Diagnostic Set 06 - Detail of Functional Components for ENT Diagnostic Set 07 - Information of Manufacturing Process for ENT Diagnostic Set 08 - Instruction Manual for ENT Diagnostic Set 09 - Label Samples for ENT Diagnostic Set 10 - Lot Code Interpretation for ENT Diagnostic Set 11 - Risk Analysis for Bandage ENT Diagnostic Set 12 - Sterilization Guideline for ENT Diagnostic Set 13 - Technical Data Sheet for ENT Diagnostic Set 14 - Technical Sheet of Packaging and Packaging Material for ENT Diagnostic Set 15 - Technical Study & Analytical Verification for ENT Diagnostic Set

Article unique

30X25X5 cm