BC3200 Hematology Analyzer

FDA UDI

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name: BC3200 Hematology Analyzer FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Model / Reference: BC3200 FDA UDI

Identifiers

Primary DI / UDI-DI: 06944904002422 FDA UDI
FDA Product Code: GKZ FDA UDI
GMDN Term: Haematological cell analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Haematological cell analyser IVD

BC3200 Hematology Analyzer by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.

Sources (1)

FDA UDI 16af29bd-c8e5-45d9-8406-7999da5827ca 32 fields · synced Jun 1, 2026