Register Your Hematology Device in Brazil
Analyzers, reagents, blood banking equipmentโstreamlined ANVISA registration for hematology diagnostics.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
10yr
Registration Validity
Hematology IVDs Require Specialized Expertise
Specialized devices need specialized expertise
Blood Contact Complexity
Devices handling blood samples face strict contamination prevention and biohazard safety requirements.
Performance Validation
Cell counters and coagulation analyzers need extensive accuracy, precision, and linearity data.
Reagent Management
Hematology systems with proprietary reagents require coordinated registration and ongoing amendments.
We Specialize in Hematology Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Hematology analyzer and reagent system registration
Technical Documentation Excellence
Blood banking equipment expertise
Proven Registration Track Record
Coagulation testing device registration
Ongoing Compliance Support
Performance validation documentation for cell counters
How It Works
Free Consultation
Share your device details. We'll confirm classification, assess your documentation, and provide an exact quote.
Expert Dossier Preparation
Our regulatory specialists prepare your complete submission with deep specialty knowledge.
Submission & Management
We submit on your behalf and manage the entire review process, including deficiency responses.
Market Your Device
Receive your registration. Your device is legally marketable for 10 years.
Trusted by Leading Hematology Device Companies
โPure Global registered our complete hematology analyzer line. Their IVD expertise made the process smooth.โ
Dr. Amanda Foster
Regulatory Affairs Director, HemaCell Diagnostics
Transparent Pricing
Complete service, no hidden fees
Starting from
Starting from $2,000/year
Based on device class and complexitySave 60-80%
Ready to Register Your Hematology Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.