Alcalene®

by Katsan Katgüt San. Ti̇c. A.Ş. 2 variants

Ref F1204V1T15Model PP monofilament blue-colored single or with double needle or without needle; PP monofilament undyed (beige) single or with double needle or without needle

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	Number8698876ALCALENE0X4 Basic UDI-DI	Date14 May 2026Registered	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Withdrawn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

Model / Reference: PP monofilament blue-colored single or with double needle or without needle, PP monofilament undyed (beige) single or with double needle or without needle, F1204V1T15

Primary DI / UDI-DI: 08698876076292
Basic UDI-DI: 8698876ALCALENE0X4
EMDN Code: H010201010401, H010201010402

Device Class: Class IIb
Market of Registration: Türkiye

Manufacturer details

EUDAMED SRN: TR-MF-000016068

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Properties

Sterile
Implantable
Sutures

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