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Endoscopic Image Processor

EUDAMED

Class I (EU MDR)

Ref P2-H3Model P2-F1、P2-F2、P2-F3、P2-F4、P2-G1、P2-G2、P2-G3、P2-G4、P2-H1、P2-H2、P2-H3、P2-H4、P2-I1、P2-I2、P2-I3、P2-I4、P2-J1、P2-J2、P2-J3、P2-J4、P2-K1、P2-K2、P2-K3、P2-K4、P2-L1、P2-L2、P2-L3、P2-L4、P2-M1、P2-M2、P2-M3、P2-M4

by Hunan Endoso Life Technology Co., Ltd

Identity

Device Name
Endoscopic Image Processor EUDAMED
Model / Reference
P2-F1、P2-F2、P2-F3、P2-F4、P2-G1、P2-G2、P2-G3、P2-G4、P2-H1、P2-H2、P2-H3、P2-H4、P2-I1、P2-I2、P2-I3、P2-I4、P2-J1、P2-J2、P2-J3、P2-J4、P2-K1、P2-K2、P2-K3、P2-K4、P2-L1、P2-L2、P2-L3、P2-L4、P2-M1、P2-M2、P2-M3、P2-M4 EUDAMED
P2-H3 EUDAMED

Identifiers

Primary DI / UDI-DI
06975202779105 EUDAMED
Basic UDI-DI
697520277056JQ EUDAMED
Direct Marketing DI
06975202779105 EUDAMED
EMDN Code
Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Endoscopic Image Processor by Hunan Endoso Life Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hunan Endoso Life Technology Co., Ltd
EUDAMED SRN
CN-MF-000021400
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 32a4b9eb-6175-4cfb-ae42-0fe121bdc0b3 61 fields · synced Jun 18, 2026