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HugeMed

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref VLM-03Model 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-03 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06970462541486 EUDAMED
06970462546146 FDA UDI
Basic UDI-DI
69704625420217K EUDAMED
Direct Marketing DI
06970462541486 EUDAMED
510(k) Number
K222910 FDA UDI
K231118 FDA UDI
K231497 FDA UDI
K232435 FDA UDI
FDA Product Code
FAJ FDA UDI
FBN FDA UDI
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
876.1500 FDA UDI
874.4760 FDA UDI
874.4680 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

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

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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 5829ed87-7a54-45f9-8afa-baec911bbb66 61 fields · synced Jul 10, 2026
  • FDA UDI 52bf7841-f3ea-47ce-9f5b-0c060171f111 33 fields · synced May 30, 2026