HugeMed

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref HU30MModel HU30,HU30S,HU30M

by Shenzhen HugeMed Medical Technical Development Co., Ltd.

Identity

Trade Name: HugeMed EUDAMED
Single-Use Ureterorenoscope FDA UDI
Generic Name: Flexible video ureterorenoscope, single-use FDA UDI
Device Name: Single-Use Ureterorenoscope EUDAMED
Model / Reference: HU30,HU30S,HU30M EUDAMED
HU30M EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06970462541530 EUDAMED
06970462546467 FDA UDI
Basic UDI-DI: 69704625480008M EUDAMED
510(k) Number: K240374 FDA UDI
FDA Product Code: FGB FDA UDI
EMDN Code: Z12020709 UTEROSCOPES EUDAMED
GMDN Term: Flexible video ureterorenoscope, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 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	69704625480008M	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 919f6735-8b0b-4d4d-af1d-437cf135b3fd 61 fields · synced Jul 8, 2026
FDA UDI 2b964cdf-80a8-4501-8c55-af9a0e98b0e7 33 fields · synced May 30, 2026