eyeMAX(TM) PB Digital Controller

FDA UDIEUDAMED

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: eyeMAX(TM) PB Digital Controller FDA UDI
Generic Name: Flexible video choledochoscope, single-use FDA UDI
Device Name: PB Digital Controller FDA UDI
Model / Reference: BS-W-100 FDA UDI
Description: PB Digital Controller FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503571210 FDA UDI
510(k) Number: K221784 FDA UDI
FDA Product Code: FBN FDA UDI
GMDN Term: Flexible video choledochoscope, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

Category: Flexible video choledochoscope, single-use

eyeMAX(TM) PB Digital Controller by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video choledochoscope, single-use.

Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · Class II
Single-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
Flexible Video-Choledochoscope — Shanghai SeeGen Photoelectric Technology Co., Ltd · Class II
Single-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
Single-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
Single-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
Flexible Video-Choledochoscope — Shanghai SeeGen Photoelectric Technology Co., Ltd · Class II
WiScope® — OTU MEDICAL INC. · Class II

Cleared under the same submission

K221784 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

Sources (2)

FDA UDI f59c59e9-c53f-4f23-8b38-8ba05c9d29d6 35 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026