Heel Incision

by Sterilance Medical (Suzhou) Inc. 33 variants

Ref SteriHeel Plus 0.65x1.4mm

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number6945630130BG Basic UDI-DI 16945630138376UDI-DI	Date23 Mar 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Withdrawn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: Heel Incision
Model / Reference: SteriHeel Plus 0.65x1.4mm

Primary DI / UDI-DI: 16945630138376
Basic UDI-DI: 6945630130BG
Unit of Use DI: 06945630138379
EMDN Code: V010401 Lancets with safety systems, single-use

Device Class: Class IIa
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000002860
Authorised representative: Emergo Europe B.V. NL-AR-000000116

Other devices from Sterilance Medical (Suzhou) Inc.

index

Class IIa
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Class IIa
SteriLance

Class I
Heel Incision

Class IIa
X-Cut Pro

Class IIa
Vitrex

Class IIa

See all devices from Sterilance Medical (Suzhou) Inc. →

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