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Procision™ Ultrasonic Surgical System

EUDAMED

Class I (EU MDR)

Ref Procision I 000

by Shenzhen Purwell Medical Technology Co., Ltd.

Identity

Device Name
Procision™ Ultrasonic Surgical System EUDAMED
Model / Reference
Procision I 000 EUDAMED

Identifiers

Primary DI / UDI-DI
06973566720047 EUDAMED
Basic UDI-DI
697356672PH01NZ EUDAMED
EMDN Code
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

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

Category: Ultrasonic surgical system generator

Procision™ Ultrasonic Surgical System by Shenzhen Purwell Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic surgical system generator.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Unknown

CE/MDR

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Manufacturer

Manufacturer
Shenzhen Purwell Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000012094
Authorised Representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Sources (1)

  • EUDAMED 776b0e11-975b-45b7-ac0e-6cac505edbc5 61 fields · synced Jun 18, 2026