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Single-Use Choledochoscope

FDA UDIEUDAMED

Class II (US FDA UDI)

by Shenzhen HugeMed Medical Technical Development Co., Ltd.

Identity

Trade Name
Single-Use Choledochoscope FDA UDI
Generic Name
Flexible video choledochoscope, single-use FDA UDI
Model / Reference
CH-M40 FDA UDI

Identifiers

Primary DI / UDI-DI
06970462546320 FDA UDI
510(k) Number
K231497 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video choledochoscope, single-use

Single-Use Choledochoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Flexible video choledochoscope, single-use.

Cleared under the same submission

K231497 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen HugeMed Medical Technical Development Co., Ltd.

Sources (2)

  • FDA UDI 9b830f25-c1cf-4012-b308-37c20e1b77f5 33 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026