Optique 25° autoclavable

EUDAMED

Class I (EU MDR)

Ref TH1315Model 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: Optique 25° autoclavable 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
TH1315 EUDAMED

Identifiers

Primary DI / UDI-DI: 06947014623938 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

Optique 25° autoclavable 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 4d0a0c3c-ecfe-440c-8d4c-4367ba3aa22a 61 fields · synced Jun 20, 2026