Omega Depot Regulatory Intelligence

Laboratory Equipment & Consumables

Equipment, cold storage, PPE and consumable scope decisions.

Official sourcesSource-linkedLast review visible
Map a product import route
Laboratory Equipment & Consumables

Centrifuge and Laboratory Equipment Import

Which GTİP lines cover centrifuges and analysers, how CE and communiqué controls work for laboratory equipment, and why the equipment-versus-consumable split matters.

Santrifüjler ve ayırma ekipmanlarıAnaliz ve ölçüm cihazlarıGenel amaçlı laboratuvar ekipmanları
Read sourced guidance
Laboratory Equipment & Consumables

PPE, Medical Device or General-use Product?

Is a surgical mask a medical device, an FFP respirator PPE, and can it be both? How intended use sets status and which documents come from which regime.

Kişisel koruyucu donanım ve korunma ürünleriTıbbi cihaz sınırındaki koruyucu ürünlerGenel kullanıma yönelik koruyucu eşya
Read sourced guidance
Laboratory Equipment & Consumables

Laboratory Plasticware Import and Classification

Under which position are petri dishes, pipette tips and centrifuge tubes declared, when sterile plasticware gains medical status, and what volumetric marks require.

Plastik laboratuvar kapları ve sarflarıPipetler, pipet uçları ve ölçüm kaplarıSteril ve steril olmayan plastik sarf ürünleri
Read sourced guidance
Laboratory Equipment & Consumables

Gloves, Tubes, Swabs and Syringes: Product Scope

Are gloves, tubes, swabs and syringes medical devices or consumables? Scope decisions, GTİP splits, ÜTS registration and the sterile document set.

Tıbbi eldivenler ve muayene eldivenleriVakumlu tüpler ve numune kaplarıSwab ve numune alma setleri
Read sourced guidance
Laboratory Equipment & Consumables

Medical Freezers and Cooling System Imports

Which GTİP covers medical freezers, what the refrigerant gas and energy labelling rules demand, and how validation and installation are planned. The cooling import guide.

Laboratuvar ve medikal tip dondurucularSoğuk saklama dolapları ve derin dondurucularSoğutucu sistemler, üniteler ve aksamları
Read sourced guidance