HugeMed

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref CL-BModel CL-A、CL-B

by Shenzhen HugeMed Medical Technical Development Co., Ltd.

Identity

Trade Name: HugeMed EUDAMED
Single-use Biliary Pancreaticobiliary Scope FDA UDI
Generic Name: Flexible video choledochoscope, single-use FDA UDI
Device Name: Single-use Biliary Pancreaticobiliary scope EUDAMED
Model / Reference: CL-A、CL-B EUDAMED
CL-B EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06970462541554 EUDAMED
06970462546221 FDA UDI
Basic UDI-DI: 69704625421027L EUDAMED
510(k) Number: K241444 FDA UDI
FDA Product Code: FBN FDA UDI
KOM FDA UDI
NTN FDA UDI
FET FDA UDI
EMDN Code: Z12020501 CHOLEDOCOSCOPES EUDAMED
GMDN Term: Flexible video choledochoscope, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
872.3400 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

HugeMed by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	69704625421027L	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.
EUDAMED SRN: CN-MF-000010895
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 63a9fced-ae38-4290-8d17-21f5c48b31a6 61 fields · synced Jul 13, 2026
FDA UDI e200c163-1979-4995-a797-48ed56094058 33 fields · synced May 30, 2026