Intracardiac Needle Holder, Tci, 22 Cm, Titanium

EUDAMED

Class I (EU MDR)

Ref 13-2-0375-0022

by Surgical Instruments Belgium

Identity

Device Name: INTRACARDIAC NEEDLE HOLDER, TCI, 22 CM, TITANIUM EUDAMED
Model / Reference: 13-2-0375-0022 EUDAMED

Identifiers

Primary DI / UDI-DI: 05407010681703 EUDAMED
Basic UDI-DI: B-05407010681703 EUDAMED
EMDN Code: L0205 NEEDLE HOLDERS, REUSABLE EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Belgium EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Suturing needle holder, reusable

Intracardiac Needle Holder, Tci, 22 Cm, Titanium by Surgical Instruments Belgium — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Suturing needle holder, reusable.

JACOBSON NEEDLE HOLDER — SONTEC INSTRUMENTS, INC. · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
HNM Medical — HNM STAINLESS, LLC. · Class I
PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
ASELTECH — Asel Tibbi Aletler A.S. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-05407010681703	Class I	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Surgical Instruments Belgium
EUDAMED SRN: BE-MF-000029624

Sources (1)

EUDAMED 2591a4c0-7f52-4510-9ec7-a9c4388585b3 61 fields · synced Jul 19, 2026