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Ophthalmic Singleuse Pack-FMS-Singleuse

EUDAMED

Class IIa (EU MDR)

Ref FMSC200001Model FMSC100001,FMSC200001, FMSC300001, FMSC100101-FMSC100104, FMSC100201-FMSC100204, FMSC200101-FMSC200104, FMSC200201-FMSC200204, FMSC300101-FMSC300104, FMSC30020-FMSC300204

by Innolcon Medical Technology (Suzhou) Co., Ltd.

Identity

Trade Name
Ophthalmic Singleuse Pack-FMS-Singleuse EUDAMED
Device Name
Ophthalmic Singleuse Pack-FMS-Singleuse EUDAMED
Model / Reference
FMSC100001,FMSC200001, FMSC300001, FMSC100101-FMSC100104, FMSC100201-FMSC100204, FMSC200101-FMSC200104, FMSC200201-FMSC200204, FMSC300101-FMSC300104, FMSC30020-FMSC300204 EUDAMED
FMSC200001 EUDAMED

Identifiers

Primary DI / UDI-DI
06972464943053 EUDAMED
Basic UDI-DI
697246494MD03100FSM001XF EUDAMED
EMDN Code
Q020680 PHACOEMULSIFICATION DEVICES - ACCESSORIES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

Yes

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

Ophthalmic Singleuse Pack-FMS-Singleuse by Innolcon Medical Technology (Suzhou) Co., Ltd. — Class IIa — 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
Innolcon Medical Technology (Suzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000012689
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 0f4b2183-9131-4e21-a9aa-2c9c6b57e7b2 61 fields · synced Jun 18, 2026