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eyeMAX(TM) Single-use Video Pancreaticobiliary Scope

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name
eyeMAX(TM) Single-use Video Pancreaticobiliary Scope FDA UDI
Generic Name
Flexible video choledochoscope, single-use FDA UDI
Device Name
Minimum Required Working Channel :4.2mm,Minimum Working Channel Width:2.0mm FDA UDI
Model / Reference
CDS11008 FDA UDI
Description
Minimum Required Working Channel :4.2mm,Minimum Working Channel Width:2.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
06932503563703 FDA UDI
510(k) Number
K221784 FDA UDI
FDA Product Code
KQM FDA UDI
GMDN Term
Flexible video choledochoscope, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Pore Size — 2.0 Millimeter FDA UDI
Outer Diameter — 3.9 Millimeter FDA UDI

Category: Flexible video choledochoscope, single-use

eyeMAX(TM) Single-use Video Pancreaticobiliary Scope by Micro-Tech (Nanjing) Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video choledochoscope, single-use.

Cleared under the same submission

K221784 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

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

Sources (1)

  • FDA UDI 253e80ac-8904-4e2f-bd3c-afea7c8ff443 36 fields · synced Jun 1, 2026