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Holding sleeve, for 4.0/4.5mm cannulated screws

EUDAMED

Class I (EU MDR)

Ref B-ISC-4503

by Bioretec Ltd.

Identity

Trade Name
Holding sleeve, for 4.0/4.5mm cannulated screws EUDAMED
Activa Instrument EUDAMED
Device Name
Holding Sleeve EUDAMED
Holding sleeve, for 4.0/4.5mm cannulated screws EUDAMED
Model / Reference
B-ISC-4503 EUDAMED

Identifiers

Primary DI / UDI-DI
06438394005242 EUDAMED
Basic UDI-DI
6438394INS013WM EUDAMED
B-06438394005242 EUDAMED
Direct Marketing DI
06438394005242 EUDAMED
EMDN Code
L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Holding sleeve for 4.0/4.5mm cannulated screws offers a secure and reliable way to hold implantable devices in place, ensuring proper positioning and minimizing the risk of complications. This medical device is designed for use in various surgical procedures, providing a stable foundation for implantation.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Bioretec Ltd.
EUDAMED SRN
FI-MF-000001328

Sources (2)

  • EUDAMED 97de16e5-0b0f-436c-9449-5d9488c041a1 61 fields · synced Jul 16, 2026
  • EUDAMED 5c363b5a-6c72-4821-95a1-d3f1bb927567 61 fields · synced May 17, 2026