Gaine interne F19

EUDAMED

Class I (EU MDR)

Ref N4224 KModel PG-VA, PG-VB,PG-VC,XPG-II, PPS-II, DS-II, SS-II, NS-II, NQ-II, XNQ-I

by Hangzhou Hawk Optical Electronic Instruments Co., Ltd.

Identity

Trade Name: Gaine interne F19 EUDAMED
Device Name: Cysto-Urethroscopes EUDAMED
Model / Reference: PG-VA, PG-VB,PG-VC,XPG-II, PPS-II, DS-II, SS-II, NS-II, NQ-II, XNQ-I EUDAMED
N4224 K EUDAMED

Identifiers

Primary DI / UDI-DI: 06947014623983 EUDAMED
Basic UDI-DI: 69470146RJ00000110P7 EUDAMED
EMDN Code: Z12020702 CYSTOURETHROSCOPES EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Gaine interne F19 by Hangzhou Hawk Optical Electronic Instruments 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	69470146RJ00000110P7	Class I	Active

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Manufacturer

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
EUDAMED SRN: CN-MF-000028791
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

EUDAMED 5c19cf02-a42c-4125-890a-5119115f5113 61 fields · synced Jul 29, 2026