Blue 400

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name: BLUE 400 FDA UDI
Generic Name: Neurosurgical microscope FDA UDI
Device Name: accessory for surgical microscopes FDA UDI
Model / Reference: 7015 FDA UDI
Description: accessory for surgical microscopes FDA UDI

Identifiers

Primary DI / UDI-DI: 04049539070159 FDA UDI
510(k) Number: K240215 FDA UDI
FDA Product Code: QFX FDA UDI
GMDN Term: Neurosurgical microscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4950 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Neurosurgical microscope

Blue 400 by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical microscope.

Surgical Microscope MM90/YOH — MITAKA KOHKI CO., LTD. · Class I
Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC · Class II
Lumbar Interbody Fusion System (OLLIF) — ADVANCED RESEARCH MEDICAL LLC · Class II
AESCULAP — AESCULAP, INC. · Class I
RE3 — DIGITAL SURGERY SYSTEMS, INC · Class I
Surgical Microscope MM80/YOH — MITAKA KOHKI CO., LTD. · Class I
Surgical Microscope MM80/SS1 — MITAKA KOHKI CO., LTD. · Class I
Surgical Microscope MM51/SS1 — MITAKA KOHKI CO., LTD. · Class I

Cleared under the same submission

K240215 also covers:

BLUE 400 S — Carl Zeiss Meditec AG

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: Carl Zeiss Meditec AG

Sources (1)

FDA UDI bc4ac758-a53d-422f-917d-09ebf843497d 34 fields · synced May 31, 2026