Prolene

by Ethicon, LLC. 519 variants

Ref KBL5691JGModel PROLENE Suture

Active European Union

CE MDR

Valid until

4 Jul 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	NumberMDR 719658	Date5 Jun 2026Issued	StatusActive expires 4 Jul 2028
European Union	CE/MDR	Number0705031a012574X Basic UDI-DI	Date15 Dec 2025Registered	StatusActive

Certificates

1 certificate · EUDAMED

MDR 719658 Active Supplemented

Technical documentation EU MDR

Notified body

BSI Group The Netherlands B.V. 2797

Issued
5 Jun 2026

Expires
4 Jul 2028

Reason
Other

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: PROLENE Suture
Model / Reference: PROLENE Suture, KBL5691JG

Primary DI / UDI-DI: 10705031100947
Basic UDI-DI: 0705031a012574X
EMDN Code: H010201010401, H010201010402

Device Class: Class III
Market of Registration: Belgium

Manufacturer details

EUDAMED SRN: US-MF-000013111
Authorised representative: Johnson & Johnson Medical GmbH DE-AR-000007712

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Properties

Sterile
Implantable

Other properties (11)

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