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Imaging Processor System (Including Light Source)

EUDAMED

Class I (EU MDR)

Ref PL-2000Model PL-1000,PL-2000,PL-2100

by Shanghai SeeGen Photoelectric Technology Co., Ltd.

Identity

Device Name
Imaging Processor System (Including Light Source) EUDAMED
Model / Reference
PL-1000,PL-2000,PL-2100 EUDAMED
PL-2000 EUDAMED

Identifiers

Primary DI / UDI-DI
06973786290115 EUDAMED
Basic UDI-DI
697378629PL7K EUDAMED
EMDN Code
Z12020406 VIDEO PROCESSORS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Imaging Processor System (Including Light Source) by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class I — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000015374
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED a6e6ff7c-6a86-46d7-924a-3086cc3e68b9 61 fields · synced Jun 19, 2026