HugeMed

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref VLM-02Model VLM-02,VLM-03

by Shenzhen HugeMed Medical Technical Development Co., Ltd.

Identity

Trade Name: HugeMed EUDAMED
Image Processor FDA UDI
Generic Name: Endoscopic video image processing unit FDA UDI
Device Name: Medical Image Processor EUDAMED
Model / Reference: VLM-02,VLM-03 EUDAMED
VLM-02 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06970462541363 EUDAMED
06970462546122 FDA UDI
Basic UDI-DI: 69704625420217K EUDAMED
Direct Marketing DI: 06970462541363 EUDAMED
510(k) Number: K222910 FDA UDI
K232435 FDA UDI
FDA Product Code: EOB FDA UDI
EOQ FDA UDI
EMDN Code: Z12020406 VIDEO PROCESSORS EUDAMED
GMDN Term: Endoscopic video image processing unit FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 874.4760 FDA UDI
874.4680 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

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

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	69704625420217K	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 8db6dbb5-77af-4b04-9a54-f06548518308 61 fields · synced May 31, 2026
FDA UDI 00bd18ef-4db1-4a80-be49-1fe7bbe9779d 33 fields · synced May 30, 2026