Incision Device (Gentleheel)

by GRI Medical & Electronic Technology Co., Ltd. 11 variants

Ref PGH4X250C

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69319181F028L7 Basic UDI-DI 16931918190686UDI-DI	Date26 May 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Incision Device (Gentleheel)
Model / Reference: PGH4X250C

Primary DI / UDI-DI: 16931918190686
Basic UDI-DI: 69319181F028L7
EMDN Code: V010401 Lancets with safety systems, single-use

Device Class: Class IIa
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000004203
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Other devices from GRI Medical & Electronic Technology Co., Ltd.

Underpads

Class I
Surgical Drapes

Class I
Equipment Covers

Class I
Procedure pack

Class IIa
Surgical Gowns

Class I
Basins and Trays

Class I

See all devices from GRI Medical & Electronic Technology Co., Ltd. →

Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No