HugeMed

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref CL-AModel 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-A EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06970462541547 EUDAMED
06970462546214 FDA UDI
Basic UDI-DI: 69704625421027L EUDAMED
510(k) Number: K241444 FDA UDI
FDA Product Code: FBN FDA UDI
KQM 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
878.4160 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

Is this your device? Claim it to add documentation and request validation.

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 f824f271-bd0c-40a1-abe7-72e7005d8ec4 61 fields · synced Aug 3, 2026
FDA UDI 95c5ea67-4393-4be1-8f6e-11e7adfb01fa 33 fields · synced May 24, 2026