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Miconvey

EUDAMED

Class IIb (EU MDR)

Ref EFCC60-2.5RModel EFCC60-2.5R, EFCC60-2.5P, EFCC60-3.5P, EFCC45-2.5R, EFCC45-2.5P, EFCC45-3.5P

by Miconvey Technologies Co., Ltd.

Identity

Trade Name
Miconvey EUDAMED
Device Name
Single Use Loading Unit EUDAMED
Model / Reference
EFCC60-2.5R, EFCC60-2.5P, EFCC60-3.5P, EFCC45-2.5R, EFCC45-2.5P, EFCC45-3.5P EUDAMED
EFCC60-2.5R EUDAMED

Identifiers

Primary DI / UDI-DI
06979066041439 EUDAMED
Basic UDI-DI
697471025EFCCJ8 EUDAMED
EMDN Code
H02020199,H02030199 EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

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

Miconvey by Miconvey Technologies Co., Ltd. — Class IIb — 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

EUDAMED SRN
CN-MF-000031532
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED b02d6ddb-dc25-4861-9557-cd11216f322c 61 fields · synced Jun 9, 2026