Auto Hematology Analyzer(FDA) BC-3600

FDA UDIEUDAMED

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name: Auto Hematology Analyzer(FDA) BC-3600 FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Model / Reference: BC-3600 FDA UDI

Identifiers

Primary DI / UDI-DI: 06944904027883 FDA UDI
510(k) Number: K160429 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

Auto Hematology Analyzer(FDA) BC-3600 by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — IVDD, IVDR, FDA UDI — listed in FDA GUDID, EUDAMED

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Cleared under the same submission

K160429 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Unknown
EUDAMED	European Union	IVDR	—	Class II	Unknown
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 (2)

FDA UDI 47742ad5-75c6-4eac-a1c2-9506d53cf648 34 fields · synced May 30, 2026
EUDAMED 1 fields · synced May 29, 2026