Gaine externe F24

EUDAMED

Class I (EU MDR)

Ref N5810 HModel 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 externe F24 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
N5810 H EUDAMED

Identifiers

Primary DI / UDI-DI: 06947014618675 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 externe F24 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

Is this your device? Claim it to add documentation and request validation.

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 b87327a8-15a5-471d-b034-1693292d8656 61 fields · synced Jul 30, 2026